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A Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications | Clinical Trials | Clareo Health

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A Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications

A Randomized, Double-Blind Crossover Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications

NCT07012317•Midwest Center for Metabolic and Cardiovascular Research

View on ClinicalTrials.gov

Summary

The objective of this study is to assess self-reported gastrointestinal (GI) responses to three snack bars containing fiber/fiber blends vs. a control snack bar for 7 days each in adults using GLP-1 agonists.

Eligibility

Age

25 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female 25 to 64 years of age, inclusive. There will be approximately equal numbers of men and women.
•2. Individual has a self-reported BMI of 18.5 to 39.9 kg/m2, inclusive.
•3. Individual has been taking tirzepatide (≥10 mg weekly injection), semaglutide (≥2.0 mg weekly injection), or liraglutide (≥2.4 mg daily injection) for at least 4 weeks and plans to continue to take it throughout the duration of the study.
•4. Individual has attained a high school diploma or a General Educational Development (GED) equivalent.
•5. Individual has not participated in another research study within 30 days of the screening visit.
•6. Individual is willing and able to undergo the scheduled study procedures.
•7. Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria

•1. Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important GI, cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator. Clinically important GI conditions included but are not limited to: inflammatory bowel disease, irritable bowel syndrome, gastroparesis, clinically important lactose intolerance.
•2. Individual habitually consumes \>8 g fiber per 1000 kcal per day.
•3. Individual had a recent (within two weeks of screening) episode of acute GI illness such as nausea, vomiting, or diarrhea.
•4. Individual has a history of frequent diarrhea or constipation prior to beginning GLP-1 receptor agonist that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
•5. Individual has a history of stomach or GI surgery (e.g., gastric bypass, cholecystectomy) that in the opinion of the Investigator, could interfere with evaluation of the study outcomes.
•6. Individual uses medications (over-the counter or prescription) or dietary supplements known to influence gastrointestinal motility including laxatives, enemas, or suppositories; prokinetic drugs; anti-diarrheal agents, anti-spasmotics; fiber supplements; and prebiotic and probiotic supplements (Appendix 6). A 14-day washout phase prior to day 1 is allowed for participants taking any of these products.
•7. Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
•8. Individual has a history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
•9. Individual has a history of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
•10. History of any major trauma or major surgical event within 2 months of visit 1.
+9 more criteria

Locations (2)

Excellence Medical and Research

Miami Gardens, Florida, United States

Health Awareness

Port Saint Lucie, Florida, United States

Key Dates

Start Date

May 29, 2025

Primary Completion Date

November 24, 2025

Completion Date

November 24, 2025

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

Gastrointestinal SymptomsWeight LossGLP-1

Interventions

High Fiber Bar with Inulin

OTHER

High Fiber bar with Fiber Blend

OTHER

High Fiber Bar with Resistant Starch type 4

OTHER

Low Fiber Bar

OTHER

Protein Supplementation Intervention on Body Weight

NCT06989203

ObesityWeight Loss+1 more

View study

RECRUITINGPHASE3

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

NCT07104383

Weight Loss

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RECRUITINGNA

WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications

Inclusion Criteria

Exclusion Criteria

Protein Supplementation Intervention on Body Weight

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)

Dyad Plus Effectiveness/Feasibility

Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults