Recruiting

Prebiotic Soda

Sponsor:

Olipop, PBC

Code:

NCT07298135

Conditions

Blood Glucose Control

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Interventions

Prebiotic Soda

Active Control

Study Details

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

Study ID

NCT07298135

Start date

Dec 17, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

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 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
  • Person who is pregnant, planning pregnancy, or lactating
  • Any condition the Investigator believes would interfere with study participation or compliance
  • Consumption of more than 5 prebiotic sodas within the last 30 days prior to enrollment
  • Heavy smoker as defined as smoking 20 or more cigarettes per day, or smoked roughly 1 pack a day for 20+ years (more than 20 pack years)

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Effects on Fasting Plasma Glucose [ Time Frame: Baseline to 8 weeks ]

Central Contacts and Locations

Central contacts

Megha Doshi

megha@peoplescience.health

People Science

ps48metabolichealthstudy@peoplescience.health

Locations

People Science

Recruiting

Los Angeles, California, United States, 90045

Contacts

People Science

ps48metabolichealthstudy@peoplescience.health

More Information

Sponsor

Olipop, PBC

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Olipop, PBC on 2026-07-01.