Viome Nutritional Programs for Mental Health Conditions

N/A

Waitlist Available

Led By Momchilo Vuyisich

Research Sponsored by Viome

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ~4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is for US residents with mental health issues. They enroll by signing an informed consent form, then complete a survey. They're randomized into one of three groups, and the study is done entirely online.

Who is the study for?

This trial is for US residents aged 25-75 with mild to moderate depression or anxiety, who can read and speak English. They must be willing to follow the diet plan, not have used Viome products before, and not be on any specific diets like KETO or FODMAP. Pregnant women, those breastfeeding, postpartum under 90 days, or planning pregnancy are excluded.

What is being tested?

The study tests the VIOME Precision Nutrition Program and condition-based supplements designed by VIOME on mental health outcomes. Participants complete a survey and are randomly assigned into one of three groups without visiting clinical sites; everything is managed directly with participants.

What are the potential side effects?

Potential side effects aren't specified but may include reactions to dietary changes or supplement ingredients if allergies exist. Changes in gastrointestinal function due to diet alteration could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ~4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and ~4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation between microbial changes and clinical outcomes

Increased Quality of Life Score

Reduced GAD-7 Score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Viome's condition-based supplementsActive Control1 Intervention

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.

Group II: PlaceboActive Control1 Intervention

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 or inactive ingredients. Participants may need to use a mobile app in order to participate in the trial.

Group III: Viome's Precision Nutrition Program (VPNP)Active Control1 Intervention

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