HealthyEarly Phase 1BH-GLYNCT06630312
Glycemic Response of Whole Beans and Bean Products
A Early Phase 1 study testing Alpha galactosidase in people with Healthy and Body Mass Index, Normal, run by Iowa State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Body Mass Index, Normal, Postprandial Hyperglycemia
- What is being tested?
- Alpha galactosidase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2023to 17 Oct 2023
- Phase
- Early Phase 1
- 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 21 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
The 4 test treatments (yellow whole bean, yellow whole bean and alpha-galactosidase (AGS), yellow bean flour pasta, yellow bean flour pasta and AGS) will be administered in semi-randomized order once every four weeks. Participants will be randomized to whole beans or bean pasta, and within the meal group randomized again to receive the AGS treatment or not. Pulses will be served with a standardized amount of spaghetti sauce. The treatment intervention consisted of 16 gm of pasta sauce with either no AGS or 600 GALU of AGS.
The test participants were required to consume the entire test meal in 7-9 minutes while being observed. Venous blood samples were collected for blood glucose and insulin levels at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post treatment (timing of the post-treatment draws started at time 0 [post-treatment], which is when the participant finishes consuming the treatment meal). Triglycerides were measured at time 0, 60, 120, 180 minutes post-treatment.
Blood samples were processed according to laboratory instructions and sent out for analysis by Quest Diagnostics. Breath hydrogen samples were collected at times 0 (fasting), 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, and 180 minutes post treatment. Samples were measured at the end of the 4-hour test period in sequential order on the same calibrated instrument.
Anthropometric measures of weight, height, waist circumference, and blood pressure were collected at screening and weight, waist circumference, and blood pressure will be collected at the start of each test day. Thirteen hours before testing, participants will consume a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes. This control meal was selected by each participant before the start of the study. Each participant was provided the same frozen meal every time, since the subjects serve as their own controls. The day before test day, participants completed a 24-hour food recall, satiety, and gastrointestinal questionnaires .
During each test day participants completed satiety questionnaires, sensory questionnaires, and a gastrointestinal questionnaire. Satiety questionnaires were completed every 45 minutes after the first bite. The sensory questionnaire was completed immediately following the entire test meal being eaten. The gastrointestinal questionnaire was completed the evening before the test day, at 165 minutes following the first bite of the test meal, the evening of testing, and the following evening.
- Conditions
- Healthy, Body Mass Index, Normal, Postprandial Hyperglycemia
- Being tested
- Alpha galactosidase, Placebo
- Keywords
- Normoglycemia, Glucose, postprandial, Insulin, alpha galactosidase, young adults
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha galactosidaseDietary supplement
Also called Beano
Alpha galactosidase capsule, 600 GALU, manufacturer Equate brand, Walmart. Powder contents from one capsule were stirred into 16 g spaghetti sauce and served before the main meal.
PlaceboDietary supplement
Placebo is 16 gm of spaghetti sauce served before the meal in a condiment cup. It is the same set up as the intervention except the \'intervention\' contains the AGS.
| Study group | Role | What they receive |
|---|---|---|
| Yellow beans | Placebo comparator | Yellow beans, cooked in spaghetti sauce Receives: Dietary Supplement: Placebo |
| Yellow beans with AGS | Experimental | Yellow beans, cooked in spaghetti sauce, with AGS treatment Receives: Dietary Supplement: Alpha galactosidase |
| Yellow bean pasta | Placebo comparator | Yellow bean pasta with spaghetti sauce Receives: Dietary Supplement: Placebo |
| Yellow bean pasta with AGS | Experimental | Not described Receives: Dietary Supplement: Alpha galactosidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
Venous blood sample of glucose
Measured: Time 0 (fasting), then every 30 minutes for 3 hours
Secondary outcomes (5)
Postprandial insulin
Venous blood sample of insulin
Measured: Time 0 (fasting), then every 30 minutes for 3 hours
Postprandial triglycerides
Venous blood sample of triglycerides
Measured: Time 0 (fasting), then every 60 minutes for 3 hours
Satiety or Appetite evaluation
Participant completion of satiety and appetite ranking survey. Satiety level measured using a visual analog scale (0-100). A higher score indicates greater satiety.
Measured: Time 0 (fasting), then 45 minutes post-ingestion, and 30 minutes after that for seven data points
Breath hydrogen
Participants blew into Quintron \& Easy Sampler device for breath hydrogen measures before testing, and post-ingestion of the test meal for 3 hours.
Measured: Time 0 (fasting), then every 15 minutes for 3 hours
Gastrointestinal symptoms
Participants completed symptom check list for flatulence, bloating, belching, and the Bristol Stool chart for the pre-test day, evening after testing, and post-test day.
Measured: Pre-test day, evening of testing in the am, and evening on the day after testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start28 Mar 2023
- Primary completion27 Jun 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna Winham, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630312
- Sponsor's protocol ID
- 22-375-00
- Other IDs
- 58-5050-8-009
- Acronym
- BH-GLY
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I am willing to share if I am asked about it. I do not plan to upload to a data repository at this time.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Response of Whole Beans and Bean Products
- ClinicalTrials.gov ID
- NCT06630312
- Acronym / sponsor ID
- BH-GLY / 22-375-00
- Conditions
- Healthy, Body Mass Index, Normal, Postprandial Hyperglycemia
- Keywords
- Normoglycemia, Glucose, postprandial, Insulin, alpha galactosidase, young adults
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 8 Oct 2024 (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 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.
Detailed description
The 4 test treatments (yellow whole bean, yellow whole bean and alpha-galactosidase (AGS), yellow bean flour pasta, yellow bean flour pasta and AGS) will be administered in semi-randomized order once every four weeks. Participants will be randomized to whole beans or bean pasta, and within the meal group randomized again to receive the AGS treatment or not. Pulses will be served with a standardized amount of spaghetti sauce. The treatment intervention consisted of 16 gm of pasta sauce with either no AGS or 600 GALU of AGS.
The test participants were required to consume the entire test meal in 7-9 minutes while being observed. Venous blood samples were collected for blood glucose and insulin levels at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post treatment (timing of the post-treatment draws started at time 0 [post-treatment], which is when the participant finishes consuming the treatment meal). Triglycerides were measured at time 0, 60, 120, 180 minutes post-treatment.
Blood samples were processed according to laboratory instructions and sent out for analysis by Quest Diagnostics. Breath hydrogen samples were collected at times 0 (fasting), 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, and 180 minutes post treatment. Samples were measured at the end of the 4-hour test period in sequential order on the same calibrated instrument.
Anthropometric measures of weight, height, waist circumference, and blood pressure were collected at screening and weight, waist circumference, and blood pressure will be collected at the start of each test day. Thirteen hours before testing, participants will consume a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes. This control meal was selected by each participant before the start of the study. Each participant was provided the same frozen meal every time, since the subjects serve as their own controls. The day before test day, participants completed a 24-hour food recall, satiety, and gastrointestinal questionnaires .
During each test day participants completed satiety questionnaires, sensory questionnaires, and a gastrointestinal questionnaire. Satiety questionnaires were completed every 45 minutes after the first bite. The sensory questionnaire was completed immediately following the entire test meal being eaten. The gastrointestinal questionnaire was completed the evening before the test day, at 165 minutes following the first bite of the test meal, the evening of testing, and the following evening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Yellow beans | Placebo comparator | Dietary Supplement: PlaceboYellow beans, cooked in spaghetti sauce |
| Yellow beans with AGS | Experimental | Dietary Supplement: Alpha galactosidaseYellow beans, cooked in spaghetti sauce, with AGS treatment |
| Yellow bean pasta | Placebo comparator | Dietary Supplement: PlaceboYellow bean pasta with spaghetti sauce |
| Yellow bean pasta with AGS | Experimental | Dietary Supplement: Alpha galactosidase |
Who may qualify
- Ages
- 21 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Alpha galactosidaseAlso: BeanoAlpha galactosidase capsule, 600 GALU, manufacturer Equate brand, Walmart. Powder contents from one capsule were stirred into 16 g spaghetti sauce and served before the main meal. | Dietary supplement | Yellow bean pasta with AGS, Yellow beans with AGS |
| PlaceboPlacebo is 16 gm of spaghetti sauce served before the meal in a condiment cup. It is the same set up as the intervention except the \'intervention\' contains the AGS. | Dietary supplement | Yellow bean pasta, Yellow beans |
Primary outcome
Postprandial glucose
Time frame: Time 0 (fasting), then every 30 minutes for 3 hours
Venous blood sample of glucose
5 secondary outcomes
Postprandial insulin
Time frame: Time 0 (fasting), then every 30 minutes for 3 hours
Postprandial triglycerides
Time frame: Time 0 (fasting), then every 60 minutes for 3 hours
Satiety or Appetite evaluation
Time frame: Time 0 (fasting), then 45 minutes post-ingestion, and 30 minutes after that for seven data points
Breath hydrogen
Time frame: Time 0 (fasting), then every 15 minutes for 3 hours
Gastrointestinal symptoms
Time frame: Pre-test day, evening of testing in the am, and evening on the day after testing
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 Oct 2024.
- Individual participant dataSharing planned: Undecided. I am willing to share if I am asked about it. I do not plan to upload to a data repository at this time.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alpha galactosidase in people with Healthy and Body Mass Index, Normal, run by Iowa State University at 1 site 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 8 inclusion and 14 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postprandial glucose (time frame: Time 0 (fasting), then every 30 minutes for 3 hours). 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 Oct 2024.