Anxiety, Anxiety Depression, Anxiety Disorders, Anxiety State, Depression, Depression, Anxiety, Mental Health, Mental Health Disorder, Mental Health Issue
Conditions
Keywords
Mental Health, diet, supplements, vitamins, stress
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.
Interventions
COMBINATION_PRODUCTVIOME Precision Nutrition Program
Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
OTHERControl arm
Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and/or supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.
Sponsors
Viome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Once enrolled, participants are randomized into one of the 2 study arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
Intervention model description
Randomized, blinded, cohort study divided into two study arms: 1) control group (placebo), 2) precision-supplement
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PHQ-9 Score | 4 months | Change in PHQ-9 score for VPNP group compared to baseline scores. |
| Change in GAD-7 Score | 4 months | Change in GAD-7 score for VPNP group compared to baseline scores. |
| Change in Quality of Life Score | 4 months | Change in quality of life score for VPNP group compared to baseline scores. |
| Change in Perceived Stress Scale Score | 4 months | Change in perceived stress score for VPNP group compared to baseline scores. |
Countries
United States
Contacts
Primary ContactMory Mehrtash
Backup ContactMomchilo Vuyisich
Outcome results
None listed