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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.
Viome Life Sciences
Bothell, Washington, United States
RECRUITINGHbA1c Levels
HbA1c changes in individuals in the interventional arm compared to baseline measurement.
Time frame: 4 months
Insulin Resistance
Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.
Time frame: 4 months
BMI
Changes in BMI of individuals in the interventional arm compared to baseline measurement.
Time frame: 4 months
Cholesterol
Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.
Time frame: 4 months
Waist to Hip Ratio
Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.
Time frame: 4 months
Cardiovascular Risk
Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.
Time frame: 4 months
Patient Health Questionnaire 9 (PHQ 9) Score
Changes in PHQ9 score of those in the interventional arm compared to baseline answers. The minimum PHQ 9 score is 0 and the maximum PHQ 9 score is 27. Higher scores indicate a worse outcome.
Time frame: 4 months
General Anxiety Disorder - 7 Score
Changes in GAD7 score in those in the interventional arm compared to baseline assessment. The minimum score on GAD 7 is 0-4 indicating none to minimal anxiety and the maximum score is 15-21 indicating sever anxiety. Higher scores indicate a worse outcome.
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Time frame: 4 months
Species prevalence in stool, blood, and saliva
Changes in the prevalence of species in stool, blood, and saliva samples compared to baseline analysis.
Time frame: 4 months
Fasting glucose
Fasting glucose changes in individuals in the interventional arm compared to baseline measurement.
Time frame: 4 months