Glycemic Response of Whole Beans and Bean Products (NCT06630312) | Clinical Trial Compass
CompletedEarly Phase 1
Glycemic Response of Whole Beans and Bean Products
United States21 participantsStarted 2023-03-28
Plain-language summary
The main goal of this clinical trial is to learn if alpha-galactosidase (tradename Beano) changes in post-prandial (after-meal) blood glucose after eating whole cooked whole pulses or pulse-based pasta products in comparison to the same foods without alpha-galactosidase. Comparison of postprandial blood insulin and triglyceride levels, appetite, and gastrointestinal symptoms of flatulence, bloating, and stool changes will be evaluated by comparisons of the alpha-galactosidase and the pulse form (whole vs. pasta). In addition to blood glucose, such as flatulence and bloating, postprandial glucose, insulin, and appetite of individuals.
The study design is a 4x4 crossover and the population is healthy volunteers aged 21-34 with normal glucose response and body weight.
The primary hypothesis is that alpha-galactosidase will cause increased postprandial blood glucose for both whole and pasta pulse foods. The secondary hypothesis is that gastrointestinal symptoms will be less for both meals with the alpha-galactosidase. Other comparisons are exploratory.
Participants will come in fasting for one morning per week and receive the food treatments in randomized order. Test measurements will be taken over a four hour period.
Who can participate
Age range
21 Years – 34 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI between 20-29.9 kg/m2
* Height range of 60-74"
* HbA1C between 4.9-5.7%
* Individuals who consumed breakfast on most days
* Women who were not pregnant or lactating
* Individuals who could walk and eat independently
* Individuals who were willing to eat beans and bean pasta
* Individuals who were willing to restrict moderate and vigorous exercise, caffeine, alcohol, or herbal teas for 24 hours prior to testing
Exclusion Criteria:
* Persons who smoke cigarettes, tobacco of other kinds or e-cigarettes
* Vegetarian/Vegan
* Uncontrolled health conditions and/or diagnosis of gastrointestinal disease
* Intake of any medications and/or dietary supplements affecting glucose levels
* Individuals with HbA1C level \>5.9% at screening
* Individuals with an allergy to legumes, tomatoes, nus, wheat, or gluten
* Known latex allergy
* Known allergy to mold or alpha-galactosidase enzyme products
* Never had blood drawn before from arm
* Known difficulty with blood draws, e.g., feeling faint, or dizzy
* Individual who have had a recent weight gain or loss (\>10% over 6 months)
* Persons who work altered shifts
* Abnormal score on the Three-Factor Eating Questionnaire
* Unwillingness or inability to follow study protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postprandial glucose
Timeframe: Time 0 (fasting), then every 30 minutes for 3 hours