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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorOlipop, PBC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to provide informed consent

Willing to comply with all study procedures

Male or female, ages 30 - 70 years old

Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings (24-36 fl. oz)/daily in a typical month, representing usual dietary pattern)

Disqualifiers

Inability to consume a standard 12 fl. oz. carbonated beverage twice daily

Currently engaged or planning to be on an intensive weight loss regimen program

Extreme dietary habits in the judgement of the Investigator or has been diagnosed with an eating disorder

Habitual use of fiber supplements, inulin-based supplements, acacia fiber, glucomannan, prebiotic supplements, or probiotic supplements within 30 days of study enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prebiotic Soda

    Behavioral

    Participants 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.

  • Active Control

    Behavioral

    Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Effects on Fasting Plasma Glucose

Change in fasting plasma glucose

Time frame
Baseline to 8 weeks

Secondary outcomes

1

Effects on Long-term Glycemic Control

Change in HbA1c

Time frame
Baseline to week 8
2

Effect on insulin sensitivity

Change in fasting plasma insulin

Time frame
Baseline to week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olipop, PBC

Lead sponsor

People Science

Collaborator