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

Depression Clinical Trial

Official title:

Testing the Efficacy of Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190184
• Other study ID #: V211.3.1
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Viome
• Contact: Mory Mehrtash
• Phone: (425) 300-6933
• Email: studies[@]viome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Depression
• Anxiety Disorders
• Anxiety State
• Depression
• Depression, Anxiety
• Depressive Disorder
• Mental Disorders
• Mental Health
• Mental Health Disorder
• Mental Health Issue

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.

Other:
• Control 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.

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	Change in PHQ-9 Score	Change in PHQ-9 score for VPNP group compared to baseline scores.	4 months
Primary	Change in GAD-7 Score	Change in GAD-7 score for VPNP group compared to baseline scores.	4 months
Primary	Change in Quality of Life Score	Change in quality of life score for VPNP group compared to baseline scores.	4 months
Primary	Change in Perceived Stress Scale Score	Change in perceived stress score for VPNP group compared to baseline scores.	4 months