Viome Nutritional Programs for Mental Health Conditions
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how personalized nutrition programs might improve mental health conditions. Participants will join one of three groups: one with specific supplements, one with the VIOME Precision Nutrition Program, and one with placebo pills (inactive substances). Ideal participants are U.S. residents who have experienced mild to moderate mental health issues and can use a mobile app. The trial examines whether tailored nutrition can positively impact mental well-being. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in personalized nutrition and mental health.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using investigational drugs, you must stop at least 1 month before and for 4 months after the trial starts.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Viome's precision nutrition programs, which include supplements and dietary advice, are under study for their potential to improve mental health. Although direct safety information remains limited, the programs have passed initial safety checks to qualify for trials.
Similar studies on Viome's supplements have examined mental health and other issues like gut health. The research aims to create personalized nutrition plans using advanced technology, such as artificial intelligence, to enhance overall well-being.
Since these programs remain experimental and unapproved for mental health, it is important to recognize their status. Treatments in these trials have typically passed early safety tests, but detailed safety information is often limited at this stage.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Viome Precision Nutrition Program for mental health conditions because it offers a personalized approach to nutrition and supplementation, which is quite different from standard treatments like medications or psychotherapy. Unlike traditional treatments that may not address individual dietary needs, this program uses AI and advanced testing to tailor nutritional recommendations and supplements to each person's unique biology. This personalized approach could potentially improve mental health outcomes by targeting specific nutritional deficiencies or imbalances, which is a novel angle compared to conventional methods.
What evidence suggests that this trial's treatments could be effective for mental health conditions?
Research has shown that Viome's precision supplements, which participants in this trial may receive, can help reduce symptoms of depression. In one study, people taking these supplements saw their depression scores drop by more than 4 points on the PHQ-9 scale, which measures depression severity. This indicates a noticeable improvement in mental health. Another treatment arm in this trial involves the Viome Precision Nutrition Program, which uses scientific data to create personalized dietary recommendations based on how each person's body reacts to different foods. This tailored approach aims to improve mental health by meeting individual nutritional needs. Overall, early findings suggest these programs could be helpful for mental health conditions.12367
Who Is on the Research Team?
Momchilo Vuyisich
Principal Investigator
Viome
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized into one of three arms and receive either placebo, Viome's condition-based supplements, or Viome's Precision Nutrition Program for mental health improvement
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VIOME-designed condition-based supplements
- VIOME Precision Nutrition Program
VIOME Precision Nutrition Program is already approved in United States for the following indications:
- Mental health disorders
- Depression
- Anxiety
Find a Clinic Near You
Who Is Running the Clinical Trial?
Viome
Lead Sponsor