Using personalized nutrition to improve mental health outcomes
Testing the Efficacy of Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
This study is testing if a personalized nutrition program can help improve mental health for older adults or those with higher body weight who are dealing with depression and anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | Viome Industry-sponsored |
| Locations | 1 site (Bothell, Washington) |
| Trial ID | NCT06190184 on ClinicalTrials.gov |
What this trial studies
This study involves US residents aged 50 and older or those with a BMI of 25 or greater who are experiencing mental health issues such as depression and anxiety. Participants will be randomized into two groups: one receiving the Viome Precision Nutrition Program, which includes dietary recommendations and supplements, and the other receiving a placebo. The trial lasts approximately four months and aims to assess the impact of personalized nutrition on mental health symptoms. Participants will complete a survey upon enrollment to evaluate their mental health status.
Who should consider this trial
Good fit: Ideal candidates are US residents aged 50 and older or those with a BMI of 25 or greater who are willing to follow dietary recommendations.
Not a fit: Patients with major psychiatric disorders such as schizophrenia or bipolar disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved mental health outcomes through tailored nutritional interventions.
How similar studies have performed: While personalized nutrition approaches are gaining interest, this specific application for mental health conditions is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Resident of the United States
* 50 years old and older OR BMI of 25 or greater
* 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.