RECRUITING

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

Conditions

Mental Health Issue Depression Anxiety mental health diet supplements vitamins stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-07

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06502717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Mory Mehrtash

CONTACT

(425) 300-6933

studies@viome.com

Momchilo Vuyisich

CONTACT

(425) 300-6933

studies@viome.com

Principal Investigator

Momchilo Vuyisich

PRINCIPAL_INVESTIGATOR

Viome

Study Locations (Sites)

Viome Life Sciences

Bothell, Washington, 98011

United States

Collaborators and Investigators

Sponsor: Viome

Momchilo Vuyisich, PRINCIPAL_INVESTIGATOR, Viome

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-07

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

mental health
diet
supplements
vitamins
stress

Additional Relevant MeSH Terms

Mental Health Issue
Depression
Anxiety