Clinical trial NCT06190184: Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions
Official title: Testing the Efficacy of Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Mental Health Disorder
Mental Health
Depression
Depression, Anxiety
Anxiety
Anxiety Disorders
Anxiety Depression
Anxiety State
Keywords: Mental Health
diet
supplements
vitamins
stress
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, blinded, cohort study divided into two study arms: 1) control group (placebo), 2) precision-supplement
Primary purpose: TREATMENT

Brief summary: US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.

Detailed description: Participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.

Eligibility 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

Primary outcomes:
measure: Change in PHQ-9 Score
timeFrame: 4 months
measure: Change in GAD-7 Score
timeFrame: 4 months
measure: Change in Quality of Life Score
timeFrame: 4 months
measure: Change in Perceived Stress Scale Score
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
References: