A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults

Olipop, PBC

Status: Enrolling

Conditions: Blood Glucose Control

Treatments: Behavioral: Prebiotic Soda; Behavioral: Active Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT07298135

20254308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants will be randomized to replace traditional non-diet soda with prebiotic soda

Treatment:

Behavioral: Prebiotic Soda

Control Group

Active Comparator group

Description:

Participants will be randomized to continue consumption of traditional non-diet soda.

Treatment:

Behavioral: Active Control