Studying Glucose and Appetite Response With Alternatives to Soda Pop

Last updated: April 10, 2025
Sponsor: Olipop, PBC
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

OLIPOP prebiotic soda

Traditional sugar-sweetened cola

Clinical Study ID

NCT06427915
BIO-2401
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary aim of this clinical trial is to determine the acute effects of OLIPOP (a lower sugar, high fiber prebiotic soda) consumption, compared to consumption of a commercially available sugar-sweetened soda pop, on blood glucose in response to the beverages alone and in combination with a carbohydrate-rich mixed lunch meal in free-living, generally healthy adults.This study will consist of one screening/randomization clinic visit (day 0) and one follow-up clinic visit (day 5), with participants consuming study products on their own (e.g., at home) following an assigned treatment sequence on days 1, 2, 3, and 4. The main questions answered by this trial are the impacts of a prebiotic rich soda versus a traditional soda on: 1) blood glucose levels with and without a meal, 2) perceived hunger levels, 3) perceived alertness levels and 4) total caloric intake.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, ≥18 to ≤65 years of age at visit 1a.

  2. Body mass index (BMI) of ≥25.0 kg/m2 to <35.0 kg/m2 at visit 1a.

  3. Fasting capillary (fingerstick) glucose <126 mg/dL at visit 1a. One repeat will beallowed for glucose values between ≥126 and ≤140 mg/dL (same day if subjects areconfirmed fasting or a separate day if subjects were not fasting). If a repeat istaken, the second reading will be used to determine eligibility.

  4. Willing to wear a continuous glucose monitor (CGM) sensor throughout study periodand willing to adhere to instructions/ restrictions associated with the proper useand care of the CGM.

  5. Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use duringthe study period.

  6. Non-user of marijuana and hemp products, including cannabidiol (CBD) products,within 60 d of visit 1a.

  7. Willing to avoid alcohol 24 h prior to visit 1a/1b and throughout the study.

  8. Willing to maintain habitual diet (with the exception of study products) andphysical activity patterns throughout the trial.

  9. Willing to use personal smart phone with operating system (Android version 12.0 ornewer; Apple iPhone operating system (iOS) version 16 or newer) capable ofdownloading the Dexcom G7 CGM app and the Cronometer app for diet records.

  10. Willing to adhere to all study procedures and sign forms providing informed consentto participate in the study and authorization to release relevant protected healthinformation to the Clinical Investigator.

Exclusion

Exclusion Criteria:

  1. Inability to consume a standard 12 fl. oz. carbonated beverage with or without foodwithin 15 min.

  2. Extreme dietary habits (e.g., Atkins diet, very high protein, and/or vegan) in thejudgment of the Investigator or has been diagnosed with an eating disorder.

  3. Habitual (e.g., daily) use of fiber supplements or prebiotic supplements within 30 dof visit 1a.

  4. Known allergy or sensitivity to any of the ingredients in the study products and/ormeals provided.

  5. Weight loss or gain >4.5 kg within 90 d of visit 1a.

  6. Currently or planning to be on a weight loss or weight gain/ muscle-building regimenprogram during the study.

  7. Use of vitamin C-containing supplements (including multivitamins) within 24 hours ofvisit 1a and during the study intervention period.

  8. Shift workers with eating patterns not consistent with the study product consumptionschedule.

  9. History or presence of uncontrolled and/or clinically important endocrine,cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic, dermatologic,rheumatic, and/or biliary conditions that, in the opinion of the PrincipalInvestigator, could interfere with the interpretation of the study results.

  10. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic bloodpressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1a.

  11. Gastrointestinal condition that could potentially interfere with absorption of thestudy product (e.g., inflammatory bowel syndrome, inflammatory bowel disease (Crohn's or ulcerative colitis), celiac disease, history of gastric bypass surgery).

  12. Use of oral or injectable steroids (topical and inhaled are allowed) within 90 d ofvisit 1a.

  13. Use of products containing salicylic acid (skin-care products are allowed if notused on the area surrounding the CGM sensor) within 24 hours of visit 1a/1b andduring the study intervention period. If use occurs during the intervention period (e.g., subject takes an aspirin), details of the use (e.g., time, amount, product)should be documented.

  14. Unstable use of any prescription medications that affect blood glucose levels,whereby stable is defined as no change in regimen within 90 d prior to visit 1a.Examples include diabetes medications, glucagon-like-peptide-1 (GLP-1) agonists,medications for anxiety, attention deficit/hyperactivity disorder (ADHD),depression, and other mental health problems (e.g., clozapine, olanzapine,quetiapine, and risperidone), thyroid hormone replacement medications, statins,protease inhibitors, adrenergic receptor blockers, and isotretinoin.

  15. History or presence of cancer, except non-melanoma skin cancer, within 2 years ofvisit 1a.

  16. Exposure to any non-registered drug product or has participated in anotherintervention study within 30 d prior to visit 1a.

  17. Signs or symptoms of an active infection of clinical relevance within 5 d of visit 1a. The visit may be rescheduled such that all signs and symptoms have resolved (atthe discretion of the Clinical Investigator) at least 5 d prior to visit 1a.

  18. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcoholabuse is defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 11⁄2oz. distilled spirits).

  19. History of any major trauma or major surgical event within 60 d of visit 1a.

  20. Female who is pregnant, planning to be pregnant during the study period, lactating,or is of childbearing potential and is unwilling to commit to the use of a medicallyapproved form of contraception throughout the study period. The method ofcontraception must be recorded in the source document.

  21. Any condition the Investigator believes would interfere with his ability to provideinformed consent, comply with the study protocol, or which might confound theinterpretation of the study results or put the person at undue risk.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: OLIPOP prebiotic soda
Phase:
Study Start date:
May 15, 2024
Estimated Completion Date:
June 21, 2024

Connect with a study center

  • Biofortis

    Addison, Illinois 60101
    United States

    Site Not Available

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