Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Launched by VIOME · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how personalized nutritional programs from Viome can help people with mental health conditions like depression and anxiety. The study is open to U.S. residents who are at least 50 years old or have a body mass index (BMI) of 25 or higher. To participate, individuals need to be able to read and speak English, have a certain score on a depression questionnaire (the PHQ9), and agree to follow the trial instructions.

Participants will complete a survey when they join and will be randomly assigned to one of two groups. This trial doesn't require visits to a clinic, as it is designed to be done directly through a smartphone app. It's important to note that there are some criteria that would exclude individuals from participating, such as recent significant diet changes, certain medical conditions, or specific mental health diagnoses. If you’re interested and meet the eligibility requirements, this study could be a valuable opportunity to explore how diet might improve mental health.

Gender

ALL

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