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

NCT07298135 | Active Not Recruiting

• 1 other identifier: PS48
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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 dysregulation who are habitual consumers of traditional soda.

Conditions

Blood Glucose Control

Outcome Measures

Primary Outcomes (1)

• Effects on Fasting Plasma Glucose

  Change in fasting plasma glucose

  Baseline to 8 weeks

Secondary Outcomes (2)

• Effects on Long-term Glycemic Control

  Baseline to week 8

• Effect on insulin sensitivity

  Baseline to week 8

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Prebiotic Soda

Control Group

ACTIVE COMPARATOR

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

Behavioral: Active Control

Interventions

Prebiotic Soda BEHAVIORAL

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.

Intervention

Active Control BEHAVIORAL

Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.

Control Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• People Science: collaborator
• Olipop, PBC: lead

Study Sites (1)

People Science

Los Angeles, California, 90045, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open-Label, Controlled

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 23, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)