Gastrointestinal SymptomsNCT07012317
A Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications
A study testing High Fiber Bar with Inulin, High Fiber bar with Fiber Blend and High Fiber Bar with Resistant Starch type 4 in people with Gastrointestinal Symptoms and Weight Loss, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms, Weight Loss, GLP-1
- What is being tested?
- High Fiber Bar with Inulin, High Fiber bar with Fiber Blend and High Fiber Bar with Resistant Starch type 4
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 May 2025to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
- 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).
- 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).
- Individual has been exposed to any non-registered drug product within 30 days prior to screening.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Excellence Medical and Research
Miami Gardens, Florida, 33169
Health Awareness
Port Saint Lucie, Florida, 34952
About this study
Official title: A Randomized, Double-Blind Crossover Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications
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
- Being tested
- High Fiber Bar with Inulin, High Fiber bar with Fiber Blend, High Fiber Bar with Resistant Starch type 4, Low Fiber Bar
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fiber Bar with InulinOther
Bar with Inulin - high fiber
High Fiber bar with Fiber BlendOther
Bar with a fiber blend of psyllium husk and bran fibers - high fiber
High Fiber Bar with Resistant Starch type 4Other
Bar with Resistant Starch type 4 - High Fiber
Low Fiber BarOther
Snack Bar - Low Fiber
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Inulin | Experimental | Not described Receives: Other: High Fiber Bar with Inulin |
| Experimental - Fiber Blend | Experimental | Not described Receives: Other: High Fiber bar with Fiber Blend |
| Experimental - Resistant Starch Type 4 | Experimental | Not described Receives: Other: High Fiber Bar with Resistant Starch type 4 |
| Control - Low Fiber | Placebo comparator | Not described Receives: Other: Low Fiber Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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).
For each individual component, the ratings for the 3-day baseline period and the 7-day intervention period will be summed and divided by 3 and 7, respectively, before the change from baseline is calculated.
Measured: 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: 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)
The scores for the 3-day baseline period and the 7-day intervention period will be summed and divided by the number of bowel movements that occurred during the respective period before the change from baseline is calculated.
Measured: 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.
The raitings for the 3-day baseline period and the 7-day intervention period will be summed and divided by the number of bowel movements that occurred during the respective period before the change from baseline is calculated.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start29 May 2025
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, Midwest Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012317
- Sponsor's protocol ID
- MB-2505
- Status last verified
- Jan 2026
- First submitted
- 23 May 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Crossover Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications
- ClinicalTrials.gov ID
- NCT07012317
- Acronym / sponsor ID
- MB-2505
- Conditions
- Gastrointestinal Symptoms, Weight Loss, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- 29 May 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Fiber Bar with InulinBar with Inulin - high fiber | Other | Experimental - Inulin |
| High Fiber bar with Fiber BlendBar with a fiber blend of psyllium husk and bran fibers - high fiber | Other | Experimental - Fiber Blend |
| High Fiber Bar with Resistant Starch type 4Bar with Resistant Starch type 4 - High Fiber | Other | Experimental - Resistant Starch Type 4 |
| Low Fiber BarSnack Bar - Low Fiber | Other | Control - Low Fiber |
Primary outcome
Composite GI Symptom Score
Time frame: 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.
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.
4 secondary outcomes
Change from baseline in the ratings for the individual component scores of the GIL Tolerability Questionnaire (nausea, abdominal pain, bloating, intestinal rumbling, and flatulence).
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin C Maki, PhD study director
Midwest Biomedical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fiber Bar with Inulin, High Fiber bar with Fiber Blend and High Fiber Bar with Resistant Starch type 4 in people with Gastrointestinal Symptoms and Weight Loss, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite GI Symptom Score (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.