Status:
RECRUITING
A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults
Lead Sponsor:
Olipop, PBC
Collaborating Sponsors:
Lindus Health
Conditions:
Blood Glucose Control
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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 d...
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) ...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Key Trial Info
Start Date :
December 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT07298135
Start Date
December 17 2025
End Date
May 1 2026
Last Update
March 5 2026
Active Locations (1)
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1
Lindus Health
Boston, Massachusetts, United States, 02111