Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Sponsor

Viome (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05563857

Collaborator

(none)

150

Enrollment

Location

Arms

2.4

Anticipated Duration (Months)

61.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Depression Anxiety	Combination Product: VIOME Precision Nutrition Program Dietary Supplement: VIOME-designed condition-based supplements	N/A

Detailed Description

Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with mental wellness. The trial will last approximately 4 months for each participant.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplementRandomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement

Masking:

Single (Participant)

Masking Description:

Once enrolled, participants are randomized into one of the three arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.

Primary Purpose:

Supportive Care

Official Title:

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

Actual Study Start Date :

Oct 19, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Placebo Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.
Active Comparator: Viome's Precision Nutrition Program (VPNP) Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.	Combination Product: VIOME Precision Nutrition Program Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results. Other Names: VPNP
Active Comparator: Viome's condition-based supplements Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.	Dietary Supplement: VIOME-designed condition-based supplements Pre-formulated supplements based on overall health conditions. Other Names: VCS

Arm

Intervention/Treatment

No Intervention: Placebo

Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

Active Comparator: Viome's Precision Nutrition Program (VPNP)

Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.

Combination Product: VIOME Precision Nutrition Program

Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.

Other Names:

VPNP

Active Comparator: Viome's condition-based supplements

Dietary Supplement: VIOME-designed condition-based supplements

Pre-formulated supplements based on overall health conditions.

Other Names:

VCS

Outcome Measures

Primary Outcome Measures

Reduced PHQ-9 Score [~4 months]
Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores.
Reduced GAD-7 Score [~4 months]
Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores.
Reduced Perceived Stress Scale Score [~4 months]
Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores.
Increased Quality of Life Score [~4 months]
Increased quality of life score for both VCS and VPNP groups compared to baseline scores.
Correlation between microbial changes and clinical outcomes [~4 months]
Correlation between microbial changes on VCS or VPNP with clinical outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Resident of the United States
Females and males ages 25-75 (inclusive)
Able to speak and read English
No unexplained weight loss, fevers, anemia, or blood in stool
Willing and able to follow the trial instructions, as described in the recruitment letter
Signed and dated informed consent prior to any trial-specific procedures.
PHQ9 score of 5-24 (inclusive)

Exclusion criteria

Answer of 1, 2, or 3 on question 9 of PHQ9
Unwilling to change their current diet
Prior use of Viome products or services
Antibiotic use in the previous 3 months
Pregnancy (current or planned in the next 4 months)
< 90 days postpartum
Breast feeding
Active infection
Unable or unwilling to use Viome's App on an iPhone or Android smartphone
Significant diet or lifestyle change in the previous 3 months or next 4 months, unless it is a part of the trial
Prebiotic or probiotic supplement use in the previous 30 days
Regular use (> 3 days a week) of any products specifically marketed for gut health, such as DanActive, Activia, Yakult, multi grain/prebiotic cereals/bars, etc.
Regular use (> 3 days a week) of fermented foods, such as Kefir, Miso, Natto, Tempeh, Kimchi, Sourdough, Sauerkraut, Kombucha, etc.
IBD diagnosis -Major psychiatric/DSM-5 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
Cancer therapy within the previous 1 year
Major surgery in the last 6 months or planned in the next 4 months
Chronic pain syndrome other than IBS in past year
Start of a new prescription medication within the past 3 months or the next 4 months
Allergies to any supplement ingredients listed in the screening survey
Currently on a specific diet: FODMAP, KETO, PALEO
Gastrointestinal disease including:
GI surgery except:
Appendectomy and benign polypectomy
Esophagitis
Celiac disease
GI malignancy or obstruction
Peptic Ulcer Disease
Duodenal or gastric ulcer disease