Using personalized nutrition to improve mental health outcomes
Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
This study is testing if a personalized nutrition program can help people with mental health issues feel better compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Viome Industry-sponsored |
| Locations | 1 site (Bothell, Washington) |
| Trial ID | NCT06502717 on ClinicalTrials.gov |
What this trial studies
This study involves U.S. residents with mental health issues who will be randomized into two groups: one receiving a placebo and the other receiving the Viome Precision Nutrition Program, which includes dietary recommendations and supplements aimed at alleviating symptoms of depression and anxiety. Participants will complete a survey upon enrollment and will follow the program for approximately four months. The study is designed to assess the effectiveness of personalized nutrition in improving mental health outcomes without utilizing traditional clinical sites.
Who should consider this trial
Good fit: Ideal candidates are U.S. residents aged 25-75 who experience mild to moderate depression or anxiety and are willing to follow dietary recommendations.
Not a fit: Patients with major psychiatric disorders or those unwilling to change their current diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary intervention to improve mental health symptoms in patients.
How similar studies have performed: While personalized nutrition approaches are gaining interest, this specific intervention is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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:
* Unwilling to change their current diet
* Prior use of Viome products or services
* Antibiotic use in the previous 4 weeks
* 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 1 month
* IBD diagnosis -Major psychiatric/DSM-4 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
* Allergies to any supplement ingredients listed in the screening survey
* Currently on a specific diet: FODMAP, KETO, PALEO
* Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
* 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
Where this trial is running
Bothell, Washington
- Viome Life Sciences — Bothell, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Momchilo Vuyisich — Viome
- Study coordinator: Mory Mehrtash
- Email: studies@viome.com
- Phone: (425) 300-6933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.