RECRUITING

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

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

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.

Official Title

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Quick Facts

Study Start:2022-08-22
Study Completion:2026-12-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05465616

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed and dated informed consent form and medical release prior to any trial-specific procedures are performed
  2. * Females and males aged 18 years or older
  3. * Able to speak and read English
  4. * HbA1c between 5.7-8.9% (inclusive), tested within the past 30 days
  5. * Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)
  6. * Willing and able to follow the trial instructions and Viome's Precision Nutrition Program
  7. * Willing and able to use a smartphone and Viome app.
  1. * Antibiotic use within one month of the GI test
  2. * Gestation within previous 6 month
  3. * Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
  4. * Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
  5. * On a specific diet, such as ketogenic, for the purpose of reducing HbA1c and/or weight within the previous month
  6. * Taking diet pills
  7. * Allergy to an ingredient in the MH capsule or stick pack
  8. * Currently on an investigational product
  9. * Significant surgery or medical procedure planned
  10. * Diet or lifestyle change during the trial period, besides those appropriate for trial arm Has followed Viome nutritional recommendations (foods and/or supplements)

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 Date2022-08-22
Study Completion Date2026-12-13

Study Record Updates

Study Start Date2022-08-22
Study Completion Date2026-12-13

Terms related to this study

Keywords Provided by Researchers

  • Health
  • Wellness
  • Nutrition
  • Vitamins
  • Supplements
  • Prebiotics
  • Probiotics
  • Fitness
  • Blood sugar

Additional Relevant MeSH Terms

  • Diabetes
  • Pre Diabetes