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RecruitingNCT07298135

A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults

A Randomized, Open-Label, Controlled Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults With Glucose Dysregulation

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
224 (estimated)
Sponsor
Olipop, PBC · Industry
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Accepted

Summary

The main objective of this study is to evaluate the chronic effects of replacing traditional non-diet soda with a prebiotic soda on biomarkers associated with glycemic control in adults with glucose dysregulation who are habitual consumers of traditional soda.

Detailed description

The primary aim of this clinical trial is to evaluate the effects of replacing traditional non-diet soda with a prebiotic soda (i.e., OLIPOP) over an 8 week period on markers of glucose (blood sugar) control in adults with glucose (blood sugar) dysregulation. Participants (n=224) will be habitual consumers of traditional non-diet sodas, consuming on average 2-3 servings of non-diet soda daily. Participants will be randomized to either an active control group (continued habitual traditional non-diet soda intake, 2 - 3 servings/day) or a behavioral intervention group (OLIPOP prebiotic soda, 2 cans/day, 6 g dietary fiber and 2 - 5 g total sugar per can). Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of metabolic health, including long-term glycemic control and insulin sensitivity.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPrebiotic SodaParticipants will replace traditional non-diet sodas in their diet with a prebiotic soda (OLIPOP). Participants will consume 2 cans/day (24 fl. oz/day) that will add 12 g dietary fiber/day to their diet.
BEHAVIORALActive ControlParticipants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.

Timeline

Start date
2025-12-17
Primary completion
2026-05-01
Completion
2026-05-01
First posted
2025-12-23
Last updated
2026-03-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07298135. Inclusion in this directory is not an endorsement.