RECRUITING

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

Conditions

Gastrointestinal Symptoms Weight Loss GLP-1

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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 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.

Official Title

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

Quick Facts

Study Start:2025-05-29

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07012317

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:25 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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. 11. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1. 12. Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-day washout prior to day 1 and the participant must be willing to refrain from use during the study. 13. Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. 14. Individual has an allergy, sensitivity, or intolerance to any foods. 15. Individual has extreme dietary habits (e.g., vegan, Atkins diet, etc.). 16. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 10 days prior to any visit (washout is permitted for re-scheduling of a visit). 17. Individual has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor). 18. Individual has been exposed to any non-registered drug product within 30 days prior to screening. 19. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Inclusion Criteria

Exclusion 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.

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.
11. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
12. Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-day washout prior to day 1 and the participant must be willing to refrain from use during the study.
13. Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
14. Individual has an allergy, sensitivity, or intolerance to any foods.
15. Individual has extreme dietary habits (e.g., vegan, Atkins diet, etc.).
16. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 10 days prior to any visit (washout is permitted for re-scheduling of a visit).
17. Individual has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
18. Individual has been exposed to any non-registered drug product within 30 days prior to screening.
19. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Contacts and Locations

Study Contact

Caryn G Adams, MPH

CONTACT

8123449432

cwolfe@mbclinicalresearch.com

Principal Investigator

Kevin C Maki, PhD

STUDY_DIRECTOR

MB Clinical Research and Consulting LLC

Study Locations (Sites)

Excellence Medical and Research

Miami Gardens, Florida, 33169

United States

Health Awareness

Port St Lucie, Florida, 34952

United States

Collaborators and Investigators

Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Kevin C Maki, PhD, STUDY_DIRECTOR, MB Clinical Research and Consulting LLC

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 Date2025-05-29

Study Completion Date2025-11

Study Record Updates

Study Start Date2025-05-29

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Gastrointestinal Symptoms
Weight Loss
GLP-1