A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults
NCT ID: NCT07298135
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
224 participants
INTERVENTIONAL
2026-01-31
2026-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Intervention
Participants will be randomized to replace traditional non-diet soda with prebiotic soda
Prebiotic Soda
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.
Control Group
Participants will be randomized to continue consumption of traditional non-diet soda.
Active Control
Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.
Interventions
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Prebiotic Soda
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
Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.
Eligibility Criteria
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Inclusion Criteria
* Willing to comply with all study procedures
* Ages 40 - 70 years old
* Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings/daily)
* BMI between 25 - 35 kg/m²
* Waist-to-Hip ratio ≥0.85 for Women and ≥0.9 for Men
* Fasting plasma glucose between 100 - 125 mg/dL
* Consumes ≤16 g total fiber per day to align with the current average dietary fiber intake of American adults
* Non-user or former user (cessation ≥ 12 months) of tobacco or nicotine products
* Non-user of marijuana and hemp products, including CBD products, in the previous 60 days
* Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial
Exclusion Criteria
* 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. uncontrolled 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
* 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, lactating, or unwilling to use contraception during the study period
* Any condition the Investigator believes would interfere with study participation or compliance
* Consumption of pre-biotic sodas in the previous 30 days
40 Years
70 Years
ALL
Yes
Sponsors
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Olipop, PBC
INDUSTRY
Lindus Health
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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20254308
Identifier Type: -
Identifier Source: org_study_id