Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
ConditionDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorViome
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 6.5-8.9% (inclusive), tested within the past 30 days
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Viome's Precision Nutrition Program (VPNP)
Dietary supplementNutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PlaceboNo intervention 0 interventions
Group B: Viome's Precision Nutrition Program (VPNP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HbA1c levels
HbA1c changes in individuals in the interventional arm compared to baseline measurement.
Time frame
4 months2
Fasting Insulin levels
Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.
Time frame
4 monthsSecondary outcomes
1
BMI
Changes in BMI of individuals in the interventional arm compared to baseline measurement.
Time frame
4 months2
Waist to Hip Ratio
Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.
Time frame
4 months3
Cholesterol
Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.
Time frame
4 months4
Cardiovascular Risk
Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.
Time frame
4 months Source ClinicalTrials.gov