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Nutritional Program

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
No unexplained weight loss, fevers, anemia, or blood in stool
Females and males ages 25-75 (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~4 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't had unexplained weight loss, fevers, anemia, or blood in my stool.
Select...
I am between 25 and 75 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation between microbial changes and clinical outcomes
Increased Quality of Life Score
Reduced GAD-7 Score
+2 more

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 and inactive materials. 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
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.

Find a Location

Who is running the clinical trial?

ViomeLead Sponsor
19 Previous Clinical Trials
17,387 Total Patients Enrolled
2 Trials studying Depression
10,060 Patients Enrolled for Depression
Momchilo VuyisichPrincipal InvestigatorViome
11 Previous Clinical Trials
2,612 Total Patients Enrolled
1 Trials studying Depression
60 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Viome Life Sciences
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I meantioned in the previous question that my master's thesis was investigating the gut microbiome of wildlife and have always been interested in the co-evolution of the host-GMB relationship. I have read several studies with links between mental health and the microbiome and I would really appreciate to be involved in better understanding while seeing if it can help with my depression. While I am on medication I still often feel depressed.
PatientReceived 1 prior treatment
~48 spots leftby Dec 2024