Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• HbA1c Levels [Срок оценки: 4 months]
• Insulin Resistance [Срок оценки: 4 months]

Вторичные конечные точки (8)

• BMI [Срок оценки: 4 months]
• Cholesterol [Срок оценки: 4 months]
• Waist to Hip Ratio [Срок оценки: 4 months]
• Cardiovascular Risk [Срок оценки: 4 months]
• Patient Health Questionnaire 9 (PHQ 9) Score [Срок оценки: 4 months]
• General Anxiety Disorder - 7 Score [Срок оценки: 4 months]
• Species prevalence in stool, blood, and saliva [Срок оценки: 4 months]
• Fasting glucose [Срок оценки: 4 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Viome Life Sciences — Bothell

Идентификаторы

NCT: NCT05465616 · V197

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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