RecruitingNot ApplicableNCT06502717

Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders

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


Sponsor

Viome

Enrollment

150 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 25 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether personalized nutrition and supplement programs designed by Viome (based on gut microbiome and gene expression testing) can improve symptoms of depression and anxiety compared to a standard approach. **You may be eligible if...** - You live in the United States and are between 25 and 75 years old - You can speak and read English - You have mild to moderately severe depression (PHQ-9 score between 5 and 24) - You are willing to follow a personalized dietary program and use a smartphone app - You have not had significant diet or lifestyle changes in the past month **You may NOT be eligible if...** - You have a major psychiatric diagnosis such as schizophrenia, bipolar disorder, PTSD, or OCD - You are currently pregnant, planning pregnancy in the next 4 months, breastfeeding, or less than 90 days postpartum - You have used antibiotics in the past 4 weeks or have an active infection - You have inflammatory bowel disease (IBD) or other serious GI conditions - You have had cancer treatment in the past year or major surgery in the past 6 months - You have had recent thoughts of self-harm or suicide - You already follow a FODMAP, keto, or paleo diet or have previously used Viome products Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTVIOME Precision Nutrition Program

Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.


Locations(1)

Viome Life Sciences

Bothell, Washington, United States

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NCT06502717


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