Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms

• Sponsor: Hebrew SeniorLife (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05937165
• Collaborator: (none)
• Enrollment: 6
• Arms: 2
• Anticipated Duration (Months): 10.1

Study Details

Study Description

Brief Summary

This randomized, cross-over study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.

Condition or Disease	Intervention/Treatment	Phase
Depressive Symptoms; Aging	Other: Freeze-dried Blueberry Powder	N/A

Detailed Description

Blueberries are a rich source of anti-oxidants and dietary fiber, and are recommended to consume as a part of a healthy diet. Regular consumption of blueberries as a source of dietary antioxidants may be an effective way to lower inflammation in older adults, who commonly have higher levels of inflammatory markers. However, older adults typically have a decreased efficiency of nutrient absorption and may need a higher dose of blueberries to absorb enough of the flavonoids needed to reap their benefits on inflammation. Thus, it is important for preliminary studies to pre-determine an appropriate dose of blueberry flavonoids specifically for older adults. This study aims to evaluated the preliminary impact of freeze-dried blueberry powder consumption on flavonoid bioavailability and inflammatory biomarkers in older adults. This will be an individual-level, unblinded, randomized, cross over pilot study in 6 older adults with minor levels of depressive symptoms. Eligible participants will collect a 24 hour urine sample, and then come in for the baseline assessments and provide a blood sample. Next they will be randomized to consume either the higher dose (48 g/day, equivalent ~ 2 cups of fresh blueberries) or the lower dose (24 g/day, equivalent ~1 cup of fresh blueberries) for 3 days. After 3 days they will begin collecting a 24 hour urine sample, and come in to repeat the baseline assessments and provide a blood sample. After a two week wash out period, participants will repeat the same baseline and follow-up assessments while consuming the other powder.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms
• Anticipated Study Start Date: Jul 31, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Dose Freeze-dried Blueberry Powder Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.	Other: Freeze-dried Blueberry Powder; Three day consumption of two doses of freeze-dried blueberry powder
Experimental: Higher Dose Freeze-dried Blueberry Powder Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days.	Other: Freeze-dried Blueberry Powder; Three day consumption of two doses of freeze-dried blueberry powder

Outcome Measures

Primary Outcome Measures

1. Urinary Flavonoid Biomarkers [3 days]

   Change in total flavonoid metabolites found in the urine

2. Inflammatory Biomarker C-reactive Protein [3 days]

   Change in serum C-reactive Protein

3. Inflammatory Biomarker interferon gamma [3 days]

   Change in serum interferon gamma

4. Inflammatory Biomarker interleukins 1B, 6, 8, 10 [3 days]

   Change in interleukins 1B, 6, 8, 10

5. Inflammatory Biomarker tumor necrosis factor alpha [3 days]

   Change in tumor necrosis factor alpha

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Men and women aged 65 years and older

• Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points)

Exclusion Criteria:

• Unwilling to follow the study protocol

• Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19)

• Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders

• Self-reporting history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease

• Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions

• Self-reporting history of type 1 or type 2 diabetes

• Self-reporting any history of substance or alcohol use disorder

• Allergy to blueberries

• Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs

• Are excessive tea or coffee consumers (e.g., >3 cups/day)

• Recent and consistent use of antibiotics or pro-biotics

• Currently taking or advised during the intervention to take anti-depressants

• Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hebrew SeniorLife

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hebrew SeniorLife
• ClinicalTrials.gov Identifier: NCT05937165
• Other Study ID Numbers: Pro00069826
• First Posted: Jul 10, 2023
• Last Update Posted: Jul 10, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Jul 10, 2023