A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults
Purpose
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.
Condition
- Blood Glucose Control
Eligibility
- Eligible Ages
- Between 40 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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/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
- 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. 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, Open-Label, Controlled
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
Participants will be randomized to replace traditional non-diet soda with prebiotic soda |
|
|
Active Comparator Control Group |
Participants will be randomized to continue consumption of traditional non-diet soda. |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02111
More Details
- Status
- Recruiting
- Sponsor
- Olipop, PBC
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) control in adults with glucose (blood sugar) dysregulation. 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.