A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults (NCT07298135) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults
United States224 participantsStarted 2025-12-17
Plain-language 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.
Who can participate
Age range40 Years – 70 Years
SexALL
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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 …