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

NCT07012317 | Completed

• 1 other identifier: MB-2505
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gastrointestinal Symptoms; Weight Loss; GLP-1

Outcome Measures

Primary Outcomes (1)

• Composite GI Symptom Score

  Composite GI Symptom Score is from the GI Tolerability Questionnaire. The composite score will be calculated as the sum of the individual components (nausea, abdominal pain, bloating, intestinal rumbling, and flatulence). The ratings will be coded as: 1 = none/much less than usual, 2 = less than usual, 3 = about usual, 4 = more than usual, and 5 = much more than usual. There will be one composite score per day. Baseline will be defined as the average of the composite scores for the 3-day baseline period. The value for each intervention will be defined as the average of the composite scores for the 7-day intervention period.

  Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period.

Secondary Outcomes (4)

• Change from baseline in the ratings for the individual component scores of the GIL Tolerability Questionnaire (nausea, abdominal pain, bloating, intestinal rumbling, and flatulence).

  Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period.

• The frequency of the individual component scores of the GI Tolerability Questionnaire (nausea, abdominal pain, bloating, intestinal rumbling, and flatulence) of 4 or higher (more than usual or much more than usual) during the 7-day intervention period.

  Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period.

• Change from baseline in the Bristol Stool Form Scale (BSFS)

  Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period.

• Change from baseline in the ratings of stool hardness, straining, discomfort, and incomplete evacuation.

  Measured on days 1-10, 25-34, 49-58, and 73-82 where day 1 is the virtual visit date and start of the 3-day baseline. Study product consumption begins on day 4, 28, 52, and 76 and continues for 7 days followed by a 14 day washout period.

Study Arms (4)

Experimental - Inulin

EXPERIMENTAL

Other: High Fiber Bar with Inulin

Experimental - Fiber Blend

EXPERIMENTAL

Other: High Fiber bar with Fiber Blend

Experimental - Resistant Starch Type 4

EXPERIMENTAL

Other: High Fiber Bar with Resistant Starch type 4

Control - Low Fiber

PLACEBO COMPARATOR

Other: Low Fiber Bar

Interventions

High Fiber Bar with Inulin OTHER

Bar with Inulin - high fiber

Experimental - Inulin

High Fiber bar with Fiber Blend OTHER

Bar with a fiber blend of psyllium husk and bran fibers - high fiber

Experimental - Fiber Blend

High Fiber Bar with Resistant Starch type 4 OTHER

Bar with Resistant Starch type 4 - High Fiber

Experimental - Resistant Starch Type 4

Low Fiber Bar OTHER

Snack Bar - Low Fiber

Control - Low Fiber

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Individual has not participated in another research study within 30 days of the screening visit.
• Individual is willing and able to undergo the scheduled study procedures.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
• Individual has a history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
• Individual has a history of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
• History of any major trauma or major surgical event within 2 months of visit 1.
• Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
• 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.
• 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.
• Individual has an allergy, sensitivity, or intolerance to any foods.
• Individual has extreme dietary habits (e.g., vegan, Atkins diet, etc.).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• General Mills: collaborator

Study Sites (2)

Excellence Medical and Research

Miami Gardens, Florida, 33169, United States

Location

Health Awareness

Port Saint Lucie, Florida, 34952, United States

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Inulin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Kevin C Maki, PhD

  MB Clinical Research and Consulting LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 10, 2025
• Study Start: May 29, 2025
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (2)