Impact of Prebiotic Sodas on Satiety and Metabolic Responses in Healthy Men

NCT07105826 | Recruiting

• 1 other identifier: TCU Prebiotic Sodas Study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to study healthy men aged 18-40 to explore how different beverages affect hunger, blood sugar, insulin, and a hormone called GLP-1, which helps regulate appetite and blood sugar. The tested beverages include two prebiotic sodas (Olipop and Poppi), Diet Coke, and Coca-Cola Classic. What's the study about? It aims to understand how these drinks influence how full participants feel and how the body handles sugar and hormones compared to each other. This could help us learn more about how prebiotic drinks, which may support gut health, compare to regular sugary or diet sodas. What will participants do? Participants will visit our lab at TCU (Rickel Building, rooms 256/259) four times over four weeks, with each visit lasting about 2-2.5 hours. Participants will need to fast for 8-12 hours before each visit. Here's what happens:

• First visit involves participants' consent, measurement of height and weight, and performing a finger-stick test to check blood sugar and HbA1C. Participants will also fill out questionnaires about health, diet, and beverage preferences.
• Visits 2-4: In visit 2, a DEXA scan will be performed to assess body composition. In visits 2-4, participants will drink one of the four beverages (in a random order, served in an unlabeled black container to prevent drink identification). Other variables measured at these time points include blood pressure, fasting glucose, insulin, and GLP-1. Participants will also complete questionnaires about hunger and how the drink tastes. Each visit is spaced out by a week, and the total time commitment is about 10.5 hours. The study is expected to complete participant recruitment by December 10, 2025. Who can join? Ten healthy men aged 18-40 who don't have diabetes, heart disease, kidney or liver issues, or other specific health conditions. Participants shouldn't smoke, vape, or have certain dietary habits like intermittent fasting. Participants will be screened to confirm eligibility. What are the risks? The risks are low but include discomfort from blood draws or the IV catheter, a small chance of infection, and minimal radiation exposure from the DEXA scan (similar to everyday background radiation). There's also a small risk of a data breach, but participant information will be secured with password-protected systems and use ID numbers instead of names. What do participants get? Participants will receive a DEXA scan, baseline blood sugar, and HbA1C tests. If participants have abnormal results (like high blood sugar), doctor visits would be recommended. There are no direct benefits to participants, but participation could help develop better dietary recommendations in the future. How is privacy protected? Data will be stored securely on password-protected computers and in locked lab facilities, following HIPAA rules. Blood samples will be frozen for up to 10 years for possible future research (with participants' consent) and labeled with an ID number, not participants' names. How to join? Participants will be recruited through flyers, emails, social media, and TCU classes. If interested, participants will complete an online screening form or scan a QR code on our flyer. If eligible, participants will be contacted to confirm details and explain the study further. If participants have questions or want to join, contact Dr. Elisa Marroquin at e.marroquin@tcu.edu or Matthew Loritz at m.loritz@tcu.edu. Participation is voluntary, and participants can withdraw at any time, though data will be kept for analysis.

Conditions

Olipop; Poppi; Coca Cola - Classic; Diet Coke

Keywords

Olipop; Poppi; Diet Coke; Coca Cola; GLP-1; Insulin; soda

Outcome Measures

Primary Outcomes (4)

• Glucose

  The AUC of plasma glucose concentrations will be compared between the four conditions.

  At baseline and at 15, 30, 60, 90, and 120 minutes

• Satiety

  Subjective feelings of hunger and fullness following beverage consumption will be measured using a self-created 10-point Likert-type scale in which higher numbers will mean higher satiety/fullness. Minimum score, equal to zero, means extremely hungry, whereas maximum score, equal to 10, means extremely stuffed.

  At baseline and at 15, 30, 60, 90, and 120 minutes

• Insulin

  The AUC of plasma insulin concentrations will be compared between the 4 conditions.

  At baseline and at 15, 30, 60, 90, and 120 minutes

• GLP-1

  The AUC of GLP-1 will be compared between the 4 conditions.

  At baseline and at 15, 30, 60, 90, and 120 minutes

Secondary Outcomes (2)

• Gastrointestinal Symptoms

  24h after each the visit

• Beverage Palatability

  After beverage consumption

Other Outcomes (6)

• Body Composition

  At the baseline of visit 2.

• Fasting capillary glucose

  At the baseline of visit 1

• Fasting capillary HbA1C

  At the baseline of visit 1

Study Arms (4)

Prebiotic Soda 1

EXPERIMENTAL

Olipop is a low-calorie, carbonated prebiotic beverage (\~20-35 kcal per 355 mL serving).

Other: Prebiotic Soda 1

Prebiotic Soda 2

EXPERIMENTAL

Poppi is a low-calorie, carbonated prebiotic beverage (\~20-35 kcal per 355 mL serving).

Other: Prebiotic Soda 2

Diet Coke

EXPERIMENTAL

Diet Coke is a non-caloric, carbonated beverage sweetened with artificial sweeteners. It contains zero calories and zero sugar

Other: Diet Soda

Coca Cola

EXPERIMENTAL

Coca Cola is a caloric carbonated beverage containing high fructose corn syrup as its primary sweetener. It is considered to be a high-caloric drink (140 kcal per 355 mL serving) with 39 g of sugar.

Other: Regular Coke

Interventions

Prebiotic Soda 1 OTHER

A single dose of 12 ounces of Olipop will be provided to the 10 participants while fasted. Blood samples will be collected at baseline (before the drink) and at 15, 30, 60, 90, and 120 minutes after the drink.

Prebiotic Soda 1

Prebiotic Soda 2 OTHER

A single dose of 12 ounces of Poppi will be provided to the 10 participants while fasted. Blood samples will be collected at baseline (before the drink) and at 15, 30, 60, 90, and 120 minutes after the drink.

Prebiotic Soda 2

Diet Soda OTHER

A single dose of 12 ounces of Diet Coke will be provided to the 10 participants while fasted. Blood samples will be collected at baseline (before the drink) and at 15, 30, 60, 90, and 120 minutes after the drink.

Diet Coke

Regular Coke OTHER

A single dose of 12 ounces of Regular Coke will be provided to the 10 participants while fasted. Blood samples will be collected at baseline (before the drink) and at 15, 30, 60, 90, and 120 minutes after the drink.

Coca Cola

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Biological males only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender: Male
• Age: 18-40 years
• Health Status: Healthy, with no significant medical conditions
• Body Mass Index (BMI): 18.5-24.9 kg/m²

You may not qualify if:

• Diabetes: Diagnosed diabetes (Type 1 or Type 2)
• Gastrointestinal Disorders: Any diagnosed gastrointestinal conditions (e.g., irritable bowel syndrome, inflammatory bowel disease)
• Liver Disease: Any diagnosed liver conditions
• Kidney Disease: Any diagnosed kidney conditions
• Cardiovascular Disease: Any diagnosed cardiovascular conditions
• Hypertension: Diagnosed high blood pressure
• Recent Illness or Infection: Any illness or infection within the past 30 days that could affect study outcomes
• Tobacco or Nicotine Use: Current use of tobacco or nicotine products (e.g., smoking, vaping)
• Phenylketonuria (PKU): A genetic disorder affecting phenylalanine metabolism, due to the presence of aspartame in Diet Coke
• Medication Use: Use of medications or supplements that affect glucose metabolism, insulin response, or appetite
• Intermittent Fasting: Engagement in intermittent fasting or inconsistent time-restricted feeding patterns
• Other Health Conditions: Any other health conditions that, in the opinion of the investigators, could interfere with study participation or outcomes

Sponsors & Collaborators

• Texas Christian University: lead

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76180, United States

RECRUITING

Related Publications (7)

• Steinert RE, Frey F, Topfer A, Drewe J, Beglinger C. Effects of carbohydrate sugars and artificial sweeteners on appetite and the secretion of gastrointestinal satiety peptides. Br J Nutr. 2011 May;105(9):1320-8. doi: 10.1017/S000711451000512X. Epub 2011 Jan 24.

  PMID: 21255472 BACKGROUND

• Brown RJ, Walter M, Rother KI. Ingestion of diet soda before a glucose load augments glucagon-like peptide-1 secretion. Diabetes Care. 2009 Dec;32(12):2184-6. doi: 10.2337/dc09-1185. Epub 2009 Oct 6.

  PMID: 19808921 BACKGROUND

• Kim Y, Keogh JB, Clifton PM. Consumption of a Beverage Containing Aspartame and Acesulfame K for Two Weeks Does Not Adversely Influence Glucose Metabolism in Adult Males and Females: A Randomized Crossover Study. Int J Environ Res Public Health. 2020 Dec 4;17(23):9049. doi: 10.3390/ijerph17239049.

  PMID: 33291649 BACKGROUND

• Bian X, Chi L, Gao B, Tu P, Ru H, Lu K. The artificial sweetener acesulfame potassium affects the gut microbiome and body weight gain in CD-1 mice. PLoS One. 2017 Jun 8;12(6):e0178426. doi: 10.1371/journal.pone.0178426. eCollection 2017.

  PMID: 28594855 BACKGROUND

• Ahmad SY, Friel JK, Mackay DS. Effect of sucralose and aspartame on glucose metabolism and gut hormones. Nutr Rev. 2020 Sep 1;78(9):725-746. doi: 10.1093/nutrit/nuz099.

  PMID: 32065635 BACKGROUND

• Vandeputte D, Falony G, Vieira-Silva S, Wang J, Sailer M, Theis S, Verbeke K, Raes J. Prebiotic inulin-type fructans induce specific changes in the human gut microbiota. Gut. 2017 Nov;66(11):1968-1974. doi: 10.1136/gutjnl-2016-313271. Epub 2017 Feb 17.

  PMID: 28213610 BACKGROUND

• Cani PD, Lecourt E, Dewulf EM, Sohet FM, Pachikian BD, Naslain D, De Backer F, Neyrinck AM, Delzenne NM. Gut microbiota fermentation of prebiotics increases satietogenic and incretin gut peptide production with consequences for appetite sensation and glucose response after a meal. Am J Clin Nutr. 2009 Nov;90(5):1236-43. doi: 10.3945/ajcn.2009.28095. Epub 2009 Sep 23.

  PMID: 19776140 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Elisa Marroquin, Ph.D.

CONTACT

469-491-6443; E.Marroquin@tcu.edu

Ryan Porter, Ph.D.

CONTACT

(817) 257-6868; r.porter@tcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study is a prospective, interventional study, meaning it involves actively administering interventions (in this case, beverages) to participants and measuring their effects over time. The study employs a randomized crossover model, where each participant receives all four interventions (Olipop, Poppi, Diet Coke, and Coca-Cola Classic) in a randomized order across multiple visits. This design allows each participant to serve as their own control, reducing variability due to individual differences and increasing statistical power with a smaller sample size. The study is single-blind, meaning participants are unaware of which beverage they are consuming during each visit. Beverages are served in unlabeled black containers to minimize bias in their perception of satiety, taste, or metabolic responses.

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 6, 2025
• Study Start: August 4, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)