Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Depression Clinical Trial

Official title:

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05563857
• Other study ID #: V211.3
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Viome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

US residents who have gastrointestinal issues 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 three arms. This study is direct to participant and will NOT utilize clinical sites.

Description:

Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with gastrointestinal wellness. The trial will last approximately 4 months for each participant.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Health

Intervention

Combination Product:
• VIOME 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.

Dietary Supplement:
• VIOME-designed condition-based supplements
Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.

Locations

Country	Name	City	State
United States	Viome Life Sciences	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced PHQ-9 Score	Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores.	~4 months
Primary	Reduced GAD-7 Score	Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores.	~4 months
Primary	Reduced Perceived Stress Scale Score	Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores.	~4 months
Primary	Increased Quality of Life Score	Increased quality of life score for both VCS and VPNP groups compared to baseline scores.	~4 months
Primary	Correlation between microbial changes and clinical outcomes	Correlation between microbial changes on VCS or VPNP with clinical outcomes.	~4 months