RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Carbonated Prebiotic Beverages Versus Caloric and Non-caloric Beverages on Satiety, Glucose, Insulin, and GLP-1 Response in Healthy Male Participants

Quick Facts

Study Start:2025-08-04
Study Completion:2025-12-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07105826

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Gender: Male
  2. * Age: 18-40 years
  3. * Health Status: Healthy, with no significant medical conditions
  4. * Body Mass Index (BMI): 18.5-24.9 kg/m²
  5. * Diabetes: Diagnosed diabetes (Type 1 or Type 2)
  6. * Gastrointestinal Disorders: Any diagnosed gastrointestinal conditions (e.g., irritable bowel syndrome, inflammatory bowel disease)
  7. * Liver Disease: Any diagnosed liver conditions
  8. * Kidney Disease: Any diagnosed kidney conditions
  9. * Cardiovascular Disease: Any diagnosed cardiovascular conditions
  10. * Hypertension: Diagnosed high blood pressure
  11. * Recent Illness or Infection: Any illness or infection within the past 30 days that could affect study outcomes
  12. * Tobacco or Nicotine Use: Current use of tobacco or nicotine products (e.g., smoking, vaping)
  13. * Phenylketonuria (PKU): A genetic disorder affecting phenylalanine metabolism, due to the presence of aspartame in Diet Coke
  14. * Medication Use: Use of medications or supplements that affect glucose metabolism, insulin response, or appetite
  15. * Intermittent Fasting: Engagement in intermittent fasting or inconsistent time-restricted feeding patterns
  16. * Other Health Conditions: Any other health conditions that, in the opinion of the investigators, could interfere with study participation or outcomes
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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 Locations (Sites)

Texas Christian University
Fort Worth, Texas, 76180
United States

Collaborators and Investigators

Sponsor: Texas Christian University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-04
Study Completion Date2025-12-10

Study Record Updates

Study Start Date2025-08-04
Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Olipop
  • Poppi
  • Coca Cola - Classic
  • Diet Coke