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Recruiting NCT05465616

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

No phase Interventional Diabetes Pre Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Viome's Precision Nutrition Program (VPNP).
Who it may be relevant to
Registry conditions: Diabetes, Pre Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 5.7-8.9% (inclusive) will be recruited and randomized into either the placebo or intervention group. The study duration for each participant will be approximately 90 days. At the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome. After the samples are analyzed, the participant will receive dietary recommendations (either personalized or USDA) and supplements (either personalized or placebo). The participant will follow the dietary recommendations and take the supplements for 90 days. At the end of the 90 days, the participant will once again complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome for analysis.

Interventions

  • Dietary supplement Viome's Precision Nutrition Program (VPNP)
    Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.

Primary outcome measures

  • HbA1c Levels [Time frame: 4 months]
  • Insulin Resistance [Time frame: 4 months]
Secondary outcome measures (8)
  • BMI [Time frame: 4 months]
  • Cholesterol [Time frame: 4 months]
  • Waist to Hip Ratio [Time frame: 4 months]
  • Cardiovascular Risk [Time frame: 4 months]
  • Patient Health Questionnaire 9 (PHQ 9) Score [Time frame: 4 months]
  • General Anxiety Disorder - 7 Score [Time frame: 4 months]
  • Species prevalence in stool, blood, and saliva [Time frame: 4 months]
  • Fasting glucose [Time frame: 4 months]

Eligibility criteria

Inclusion criteria

  • Signed and dated informed consent form and medical release prior to any trial-specific procedures are performed
  • Females and males aged 18 years or older
  • Able to speak and read English
  • HbA1c between 5.7-8.9% (inclusive), tested within the past 30 days
  • Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)
  • Willing and able to follow the trial instructions and Viome's Precision Nutrition Program
  • Willing and able to use a smartphone and Viome app.

Exclusion criteria

  • Antibiotic use within one month of the GI test
  • Gestation within previous 6 month
  • Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
  • Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
  • On a specific diet, such as ketogenic, for the purpose of reducing HbA1c and/or weight within the previous month
  • Taking diet pills
  • Allergy to an ingredient in the MH capsule or stick pack
  • Currently on an investigational product
  • Significant surgery or medical procedure planned
  • Diet or lifestyle change during the trial period, besides those appropriate for trial arm Has followed Viome nutritional recommendations (foods and/or supplements)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Viome Life Sciences — Bothell

Identifiers

NCT: NCT05465616 · V197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗