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
Olipop, PBC
224 participants
Dec 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- Able to provide informed consent
- Willing to comply with all study procedures
- Ages 40 - 70 years old
- Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings (24-36 fl. oz)/daily)
- BMI between 25 - 35 kg/m²
- Fasting plasma glucose between 100 - 125 mg/dL
- Low habitual dietary fiber intake, assessed using a qualitative fiber intake screening questionnaire administered at pre-screening
- Willing to maintain stable tobacco/nicotine use habits established for ≥ 90 days, with no initiation, cessation, or change in frequency during the study period
- Willing to maintain stable marijuana, hemp, and CBD product use habits established for ≥ 60 days, with no initiation, cessation, or change in frequency during the study period
- Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial
Exclusion Criteria19
- 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 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 the previous 30 days
- Known allergy or sensitivity to any of the ingredients in the study products
- History or presence of uncontrolled and/or clinically important medical conditions that could interfere with study results interpretation (ex. diabetes mellitus, CKD stage 4-5, severe liver disease/cirrhosis, uncontrolled hypertension, recent myocardial infarction or stroke (within 6 months), severe mental illness or cognitive impairment, immunodeficiency disorders, active infections).
- Gastrointestinal conditions that could potentially interfere with absorption of the study product
- Use of oral or injectable steroids in the previous 90 days
- Use of antibiotic therapy in the previous 90 days
- Unstable use of prescription medications within the previous 90 days that affect plasma glucose levels (e.g., corticosteroids, thiazide diuretics, beta-blockers (some types), antipsychotics, tacrolimus, protease inhibitors, ACE inhibitors)
- Use of any of the following prescription medications within 90 days of enrollment: Metformin, sulfonylureas, GLP-1 agonists, SGLT-2 inhibitors, insulin.
- History or presence of cancer, except non-melanoma skin cancer, in the previous 2 years
- Exposure to any non-registered drug product or participation in another intervention study in the previous 30 days
- Recent history (within 12 months) of alcohol or substance abuse
- History of major trauma or surgical event in the previous 60 days
- Person who is pregnant, planning pregnancy, or lactating
- Any condition the Investigator believes would interfere with study participation or compliance
- Consumption of more than 5 prebiotic sodas within the last 30 days prior to enrollment
- Heavy smoker as defined as smoking 20 or more cigarettes per day, or smoked roughly 1 pack a day for 20+ years (more than 20 pack years)
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Interventions
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.
Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07298135