Clinical trial NCT05465616: Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
Official title: Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Pre Diabetes
Keywords: Health
Wellness
Nutrition
Vitamins
Supplements
Prebiotics
Probiotics
Fitness
Blood sugar
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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)

Primary outcomes:
measure: HbA1c Levels
timeFrame: 4 months
measure: Insulin Resistance
timeFrame: 4 months
Secondary outcomes:
measure: BMI
timeFrame: 4 months
measure: Cholesterol
timeFrame: 4 months
measure: Waist to Hip Ratio
timeFrame: 4 months
measure: Cardiovascular Risk
timeFrame: 4 months
measure: Patient Health Questionnaire 9 (PHQ 9) Score
timeFrame: 4 months
measure: General Anxiety Disorder - 7 Score
timeFrame: 4 months
measure: Species prevalence in stool, blood, and saliva
timeFrame: 4 months
measure: Fasting glucose
timeFrame: 4 months
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
References: