NCT05465616

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Viome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Pre Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-22
• Primary completion: 2026-12-13
• Completion: 2026-12-13
• First posted: 2022-07-20
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States