Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population

Sponsor

Louisiana State University, Baton Rouge (Other)

Overall Status

Completed

CT.gov ID

NCT04398784

Collaborator

U.S. Highbush Blueberry Council (Other), Louisiana Health Care Practitioners, LLC (Other), Collective Healthcare Solutions, LLC (Other), uBiome, Inc. (Other)

Enrollment

Locations

Arms

7.4

Actual Duration (Months)

22.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot study aims to measure the effects of an intervention of 22.5 grams of freeze-dried whole blueberry powder in water drunk daily. Measures are on outcomes of depression, biological markers of inflammation and oxidative stress, and microbial populations in the intestines.

Condition or Disease	Intervention/Treatment	Phase
Depression Depression, Anxiety Inflammation	Dietary Supplement: Freeze Dried Blueberry Powder - 71717 Dietary Supplement: USHBC Blueberry Placebo Formula #114	N/A

Detailed Description

A 29 week double-blind, placebo-controlled, crossover intervention assessing the effect of a blueberries on behavioral symptoms related to depression, biological markers of inflammation and oxidative stress, and gut microbiome measures. A total of 45 participants will be randomly assigned to either a blueberry-first or placebo-first group; participants will take 22.5 grams of either freeze-dried blueberry powder or matched placebo powder mixed with water daily for 12 weeks. This period is followed by a 4 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This study will utilize a randomized, double-blind, placebo-controlled, crossover design. 60 participants with depression will be randomized into either the placebo first or blueberry first group. Randomization will be based on outcomes from behavioral measures (Major Depression Inventory and GAD-7) and a physiological measure (C-reactive protein levels) in appointment 0. The first arm will consist of 12 weeks of daily treatment and baseline (pre-intervention), mid-intervention and post-intervention assessments. Next there will be a four week washout period, after which patients will switch treatments, and the second arm will commence--identical to the first in structure. Further, the study is a repeated measures design with each participant's baseline measures serving as her or his own control.This study will utilize a randomized, double-blind, placebo-controlled, crossover design. 60 participants with depression will be randomized into either the placebo first or blueberry first group. Randomization will be based on outcomes from behavioral measures (Major Depression Inventory and GAD-7) and a physiological measure (C-reactive protein levels) in appointment 0. The first arm will consist of 12 weeks of daily treatment and baseline (pre-intervention), mid-intervention and post-intervention assessments. Next there will be a four week washout period, after which patients will switch treatments, and the second arm will commence--identical to the first in structure. Further, the study is a repeated measures design with each participant's baseline measures serving as her or his own control.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The blueberry treatment and placebo powders have been supplied by the U.S. Highbush Blueberry Council; packets are labeled either alpha or omega. The treatment powder is a freeze-dried whole blueberry powder, and the placebo is a color- and flavor-matched powder which has been used in previous trials. Only an unblinded research assistant will have knowledge of which label corresponds to blueberry or placebo. That research assistant will be in charge of: (1) Before each appointment, distributing appropriate treatment or placebo packets into closable boxes with a number corresponding to each participant. Care-providers will give closed boxes to participants at the time of assessment. (2) Re-labeling all collected data and samples with a participant code number, and sorting into appropriate groups for analysis by blinded researchers.

Primary Purpose:

Treatment

Official Title:

Effect of Whole Blueberry Powder Consumption on Depression: A Randomized, Double-blind, Placebo Controlled, Crossover Study

Actual Study Start Date :

Apr 15, 2019

Actual Primary Completion Date :

Nov 26, 2019

Actual Study Completion Date :

Nov 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 1-Blueberry First/Placebo First Participants will be randomly assigned into either blueberry-first treatment or placebo-first group.	Dietary Supplement: Freeze Dried Blueberry Powder - 71717 Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption. Other Names: Tifblue/Rubel 50/50 Blend Dietary Supplement: USHBC Blueberry Placebo Formula #114 Blueberry flavor- and color-matched placebo powder.
Other: 2-Crossover Participants who received blueberry treatment will switch to placebo and vice versa.	Dietary Supplement: Freeze Dried Blueberry Powder - 71717 Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption. Other Names: Tifblue/Rubel 50/50 Blend Dietary Supplement: USHBC Blueberry Placebo Formula #114 Blueberry flavor- and color-matched placebo powder.

Arm

Intervention/Treatment

Other: 1-Blueberry First/Placebo First

Participants will be randomly assigned into either blueberry-first treatment or placebo-first group.

Dietary Supplement: Freeze Dried Blueberry Powder - 71717

Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption.

Other Names:

Tifblue/Rubel 50/50 Blend

Dietary Supplement: USHBC Blueberry Placebo Formula #114

Blueberry flavor- and color-matched placebo powder.

Other: 2-Crossover

Participants who received blueberry treatment will switch to placebo and vice versa.

Dietary Supplement: Freeze Dried Blueberry Powder - 71717

Other Names:

Tifblue/Rubel 50/50 Blend

Dietary Supplement: USHBC Blueberry Placebo Formula #114

Blueberry flavor- and color-matched placebo powder.

Outcome Measures

Primary Outcome Measures

Major Depression Inventory (MDI) [Day 1 of treatment intervention, before treatment consumption]
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI) [Day 30 of treatment intervention]
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI) [Day 60 of treatment intervention]
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI) [Day 1 of placebo intervention, before placebo consumption]
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI) [Day 30 of placebo intervention]
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI) [Day 60 of placebo intervention]
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time, and 5=all the time; the higher the score, the more severe the depressive symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale [Day 1 of treatment intervention, before treatment consumption]
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale [Day 30 of treatment intervention]
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale [Day 60 of treatment intervention]
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale [Day 1 of placebo intervention, before placebo consumption]
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale [Day 30 of placebo intervention]
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale [Day 60 of placebo intervention]
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) [Day 1 of treatment intervention, before treatment consumption]
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) [Day 60 of treatment intervention]
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) [Day 1 of placebo intervention, before placebo consumption]
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) [Day 60 of placebo intervention]
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.

Secondary Outcome Measures

C-Reactive Protein (CRP) Measure [Immediately after enrollment, 30 days before start of intervention]
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure [Day 1 of treatment intervention, before treatment consumption]
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure [Day 30 of treatment intervention]
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure [Day 60 of treatment intervention]
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure [Day 1 of placebo intervention, before placebo consumption]
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure [Day 30 of placebo intervention]
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure [Day 60 of placebo intervention]
Biological measure of C-Reactive Protein from participant blood sample
Gut Microbiome Analysis [Day 1 of treatment intervention, before treatment consumption]
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis [Day 30 of treatment intervention]
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis [Day 60 of treatment intervention]
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis [Day 1 of placebo intervention, before placebo consumption]
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis [Day 30 of placebo intervention]
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis [Day 60 of placebo intervention]
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Leeds Sleep Evaluation Questionnaire (LSEQ) [Day 1 of treatment intervention, before treatment consumption]
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ) [Day 30 of treatment intervention]
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ) [Day 60 of treatment intervention]
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ) [Day 1 of placebo intervention, before placebo consumption]
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ) [Day 30 of placebo intervention]
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ) [Day 60 of placebo intervention]
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Concentration of reactive oxygen species (ROS) [Day 1 of treatment intervention, before treatment consumption]
Electron paramagnetic resonance (EPR) to measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS) [Day 30 of treatment intervention]
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS) [Day 60 of treatment intervention]
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS) [Day 1 of placebo intervention, before placebo consumption]
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS) [Day 30 of placebo intervention]
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS) [Day 60 of placebo intervention]
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of quinolinic acid [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of kynurenic acid [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenine [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of tryptophan [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO) [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO) [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO) [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO) [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO) [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2 [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2 [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2 [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2 [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2 [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1 [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1 [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1 [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1 [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1 [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4 [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4 [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4 [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4 [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4 [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of brain-derived neurotropic factor (BDNF) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF) [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF) [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF) [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF) [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF) [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF) [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF) [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF) [Day 1 of placebo intervention, before placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF) [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF) [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of serotonin related compound serotonin transporter (SERT) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA) [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of glutamate [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamine [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of cortisol [Day 1 of treatment intervention, before treatment consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol [Day 30 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol [Day 60 of treatment intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol [Day 1 of placebo intervention, before placebo consumption]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol [Day 30 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol [Day 60 of placebo intervention]
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6) [Day 1 of treatment intervention, before treatment consumption]
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6) [Day 30 of treatment intervention]
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6) [Day 60 of treatment intervention]
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6) [Day 1 of placebo intervention, before placebo consumption]
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6) [Day 30 of placebo intervention]
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6) [Day 60 of placebo intervention]
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) [Day 1 of treatment intervention, before treatment consumption]
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) [Day 30 of treatment intervention]
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) [Day 60 of treatment intervention]
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) [Day 1 of placebo intervention, before placebo consumption]
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) [Day 30 of placebo intervention]
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) [Day 60 of placebo intervention]
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma) [Day 1 of treatment intervention, before treatment consumption]
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma) [Day 30 of treatment intervention]
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma) [Day 60 of treatment intervention]
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma) [Day 1 of placebo intervention, before placebo consumption]
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma) [Day 30 of placebo intervention]
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma) [Day 60 of placebo intervention]
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) [Day 1 of treatment intervention, before treatment consumption]
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) [Day 30 of treatment intervention]
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) [Day 60 of treatment intervention]
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) [Day 1 of placebo intervention, before placebo consumption]
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) [Day 30 of placebo intervention]
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) [Day 60 of placebo intervention]
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with a stable diagnosis of Major Depressive Disorder (>1 year prior to enrollment)
Males and females 18-70 years of age
Subjects with sleep disruptions
Subjects currently prescribed to a non-antipsychotic mono-pharmacotherapies
English speaking subjects only (all evaluations are in English)

Subjects with the following inflammatory disorders that exhibit low to moderate symptoms:

Hypertension (mild=140/80-160/90; moderate= 160/90-180/100)
Asthma (requiring 2 or fewer inhalations of rescue inhaler per day)
Gastroesophageal reflux disease
Irritable bowel syndrome (controlled, <3 bowel movements a day)
Arthritis (controlled)
Chronic stomach ulcers (controlled)
Obesity BMI <40
Chronic pain
Fibromyalgia
Chronic Fatigue Syndrome
Type I or Type II diabetes (controlled)
Subjects that are compliant with current treatment regimens and clinic appointments
Subjects taking intermittent or infrequent doses of acetaminophen or NSAIDs
Subjects who currently smoke or have a history of smoking

Exclusion Criteria:

Subjects with current diagnosis or history of the following conditions; or subjects currently on medication for any of the following conditions:

Severe Cardiovascular disease; Heart attack/pacemaker
Cancer
Autoimmunity Disorders
Crohn's Disease or Ulcerative Colitis
Alzheimer's Disease
Parkinson's Disease
Multiple Sclerosis
Uncontrolled Diabetes: Type I or II
Severe irritable bowel disease (>3 stools per day)
Hypertension (severe >180/100)
Hypotension (<100/60)
Epilepsy
Autism Spectrum Disorder
Schizophrenia
Psychosis/Psychotic Symptoms
Uncontrolled Hypo/Hyperthyroidism
Women who are pregnant, nursing, lactating, or planning to become pregnant within timeline of study
Subjects who are blind or deaf
Subjects who are allergic to blueberries or other similar foods or drinks (e.g. wine), or subjects who are allergic to red or blue food dye agents
Subjects who do not like the taste of blueberries
Subjects who do not want to disclose information related to their Major Depressive Disorder
Subjects who do not want to be subjected to blood draws
Subjects who consume >4 cups of blueberries per week or other foods/drinks with significant polyphenol content
Subjects supplementing with elderberry syrup >4 times per week
Subjects who have a planned surgery during the timeline of the study
Subjects prescribed to antipsychotics
Subjects using acetaminophen or NSAIDS (drugs targeting pro-inflammatory paths) chronically or exceeding recommended daily doses
Subjects chronically on Decadron, Dexamethasone, or Prednisone; or other oral steroids
Subjects on any augmenting agents (the following is not an inclusive list):

Abilify (aripiprazole), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Clozaril(clozapine), Symbyax (olanzapine/fluoxetine), Geodon (ziprasidone)

Subjects supplementing with devil's claw, fenugreek, guar gum, Panax ginseng, and Siberian ginseng
Subjects who have a history of suicidal ideation or suicide attempt
Subjects with a history or record of physical violence toward self or others
Subjects who will jeopardize their job if they miss work for appointments
Subjects with a history of addiction, except cigarettes