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

NCT07298135 | 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: 30 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
• Male or female, ages 30 - 70 years old
• Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings (24-36 fl. oz)/daily in a typical month, representing usual dietary pattern)
• BMI between 25 - 35 kg/m²
• Fasting plasma glucose between 100 - 125 mg/dL or hemoglobin A1c between 5.7% - 6.4%
• 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 in the judgement of the Investigator 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 30 days of study enrollment
• 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 (i.e., 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 (i.e., IBD, celiac disease, short bowel syndrome, chronic pancreatitis, gastroparesis, active peptic ulcer disease, gastric bypass or other bariatric surgeries, severe IBS, chronic diarrhea or malabsorption syndromes, active diverticulitis)
• Use of oral or injectable steroids within 90 days of enrollment
• Use of antibiotic therapy within 90 days of enrollment
• Unstable use of prescription medications within 90 days of enrollment 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, within 2 years of enrollment
• Exposure to any non-registered drug product or participation in another intervention study within 30 days prior to enrollment
• Recent history (within 12 months) of alcohol or substance abuse
• History of major trauma or surgical event within 60 days of enrollment

Sponsors & Collaborators

• People Science: collaborator
• Olipop, PBC: lead

Study Sites (1)

People Science

Los Angeles, California, 90045, United States

RECRUITING

Central Study Contacts

Megha Doshi

CONTACT

megha@peoplescience.health

People Science

CONTACT

ps48metabolichealthstudy@peoplescience.health

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: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)