Studying Glucose and Appetite Response With Alternatives to Soda Pop

NCT06427915 | Completed

• 1 other identifier: BIO-2401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Nutrition

Outcome Measures

Primary Outcomes (1)

• Blood Glucose iAUC

  Incremental area under the curve (iAUC) for glucose from t = -30 min prior to test product consumption to t = 120 min following test-product consumption (iAUC0-120 min), where t = 0 is the start of beverage consumption either alone or in combination with a meal (depending on the test sequence).

  For 2 hours post intervention

Secondary Outcomes (10)

• Blood Glucose Cmax

  For 2 hours post intervention

• Time to Blood Glucose Cmax (Tmax)

  For 2 hours post intervention

• Blood Glucose Rise 0-2 Hours

  For 2 hours post intervention

• Blood Glucose Dip 2-3 Hours

  For time frame of 2 to 3 hours post intervention

• Blood Glucose Reduction

  For time frame of 2 to 3 hours post intervention

Study Arms (2)

Soda consumption in fasted state

EXPERIMENTAL

One 12oz serving of soda consumed alone after a 4 hour fasting period

Other: OLIPOP prebiotic soda; Other: Traditional sugar-sweetened cola

Soda consumption with a defined carbohydrate rich meal

EXPERIMENTAL

One 12oz serving of soda consumed with a defined carbohydrate rich meal after a 4 hour fasting period

Other: OLIPOP prebiotic soda; Other: Traditional sugar-sweetened cola

Interventions

OLIPOP prebiotic soda OTHER

12oz serving containing Carbonated Water, OLISMART(TM) (Cassava Root Fiber, Acacia Fiber, Guar Fiber, Nopal Cactus\*, Marshmallow Root\*, Calendula Flower\*, Kudzu Root\*), Cassava Root Syrup, Apple Juice Concentrate, Lime Juice, Natural Cola Flavor, Alpinia Galanga Root\*, Stevia Leaf\*, Himalayan Pink Salt, Green Tea Caffeine\*, Natural Caramel Flavor, Natural Vanilla Flavor, Cinnamon\* (\*Extract)

Soda consumption in fasted state; Soda consumption with a defined carbohydrate rich meal

Traditional sugar-sweetened cola OTHER

12oz serving containing carbonated water, high fructose corn syrup, caramel color, phosphoric acid, natural flavors, caffeine

Soda consumption in fasted state; Soda consumption with a defined carbohydrate rich meal

Eligibility Criteria

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

You may qualify if:

• Male or female, ≥18 to ≤65 years of age at visit 1a.
• Body mass index (BMI) of ≥25.0 kg/m2 to \<35.0 kg/m2 at visit 1a.
• Fasting capillary (fingerstick) glucose \<126 mg/dL at visit 1a. One repeat will be allowed for glucose values between ≥126 and ≤140 mg/dL (same day if subjects are confirmed fasting or a separate day if subjects were not fasting). If a repeat is taken, the second reading will be used to determine eligibility.
• Willing to wear a continuous glucose monitor (CGM) sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.
• 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 during the study period.
• Non-user of marijuana and hemp products, including cannabidiol (CBD) products, within 60 d of visit 1a.
• Willing to avoid alcohol 24 h prior to visit 1a/1b and throughout the study.
• Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial.
• Willing to use personal smart phone with operating system (Android version 12.0 or newer; Apple iPhone operating system (iOS) version 16 or newer) capable of downloading the Dexcom G7 CGM app and the Cronometer app for diet records.
• Willing to adhere to all study procedures and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

You may not qualify if:

• Inability to consume a standard 12 fl. oz. carbonated beverage with or without food within 15 min.
• Extreme dietary habits (e.g., Atkins diet, very high protein, and/or vegan) in the judgment of the Investigator or has been diagnosed with an eating disorder.
• Habitual (e.g., daily) use of fiber supplements or prebiotic supplements within 30 d of visit 1a.
• Known allergy or sensitivity to any of the ingredients in the study products and/or meals provided.
• Weight loss or gain \>4.5 kg within 90 d of visit 1a.
• Currently or planning to be on a weight loss or weight gain/ muscle-building regimen program during the study.
• Use of vitamin C-containing supplements (including multivitamins) within 24 hours of visit 1a and during the study intervention period.
• Shift workers with eating patterns not consistent with the study product consumption schedule.
• 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 Principal Investigator, could interfere with the interpretation of the study results.
• Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1a.
• Gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, inflammatory bowel disease (Crohn's or ulcerative colitis), celiac disease, history of gastric bypass surgery).
• Use of oral or injectable steroids (topical and inhaled are allowed) within 90 d of visit 1a.
• Use of products containing salicylic acid (skin-care products are allowed if not used on the area surrounding the CGM sensor) within 24 hours of visit 1a/1b and during 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.
• 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.
• History or presence of cancer, except non-melanoma skin cancer, within 2 years of visit 1a.

Sponsors & Collaborators

• Olipop, PBC: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

Location

Study Design

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

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 24, 2024
• Study Start: May 15, 2024
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

US (1)