Completed

Gastrointestinal Responses to Dietary Fibers in Adults on Weight Loss Medications

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

High Fiber Bar with Inulin

+ High Fiber bar with Fiber Blend

+ High Fiber Bar with Resistant Starch type 4

Other
Who is being recruted

Body Weight+2

+ Body Weight Changes

+ Signs and Symptoms

From 25 to 64 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorMidwest Center for Metabolic and Cardiovascular Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 29, 2025

Actual date on which the first participant was enrolled.

This study explores how different snack bars containing fiber affect the digestive system of adults who are taking GLP-1 agonists, which are medications often used for weight loss. The study aims to understand the gastrointestinal reactions people experience when consuming these fiber-rich snack bars compared to a regular snack bar. This research is important because it might help improve dietary recommendations for those using weight loss medications by identifying which types of snack bars could be more comfortable or beneficial for them. Participants in this study will be asked to eat three different kinds of fiber-containing snack bars and one regular snack bar over separate 7-day periods. During each period, participants will report any gastrointestinal symptoms they experience, allowing researchers to compare the different effects of each bar. This study does not mention specific risks, but it focuses on understanding the digestive responses to fibers, which could lead to better dietary guidance for people on GLP-1 agonists.

Official TitleA Randomized, Double-Blind Crossover Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications
NCT07012317
Principal SponsorMidwest Center for Metabolic and Cardiovascular Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsWeight Loss

Criteria

7 inclusion criteria required to participate
Male or female 25 to 64 years of age, inclusive. There will be approximately equal numbers of men and women.
Individual has a self-reported BMI of 18.5 to 39.9 kg/m2, inclusive.
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.
Individual has attained a high school diploma or a General Educational Development (GED) equivalent.
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19 exclusion criteria prevent from participating
Individual has been exposed to any non-registered drug product within 30 days prior to screening.
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.
Individual habitually consumes >8 g fiber per 1000 kcal per day.
Individual had a recent (within two weeks of screening) episode of acute GI illness such as nausea, vomiting, or diarrhea.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Excellence Medical and Research

Miami Gardens, United StatesOpen Excellence Medical and Research in Google Maps
Suspended

Health Awareness

Port Saint Lucie, United States
Completed2 Study Centers