Glycemic Response of Whole Beans and Bean Products (BH-GLY)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Postprandial Hyperglycemia; Body Mass Index, Normal
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Alpha galactosidase

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Ames, Iowa, United States, 50011
      • Iowa State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Yellow beans; Yellow beans, cooked in spaghetti sauce	Dietary supplement: Placebo; 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.
Experimental: Yellow beans with AGS; Yellow beans, cooked in spaghetti sauce, with AGS treatment	Dietary supplement: Alpha galactosidase; 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.; Other Names: Beano
Placebo Comparator: Yellow bean pasta; Yellow bean pasta with spaghetti sauce	Dietary supplement: Placebo; 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.
Experimental: Yellow bean pasta with AGS	Dietary supplement: Alpha galactosidase; 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.; Other Names: Beano

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glucose	Venous blood sample of glucose	Time 0 (fasting), then every 30 minutes for 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial insulin	Venous blood sample of insulin	Time 0 (fasting), then every 30 minutes for 3 hours
Postprandial triglycerides	Venous blood sample of triglycerides	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.	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.	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.	Pre-test day, evening of testing in the am, and evening on the day after testing

Collaborators and Investigators

• Sponsor: Iowa State University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Insulin; young adults; Normoglycemia; Glucose, postprandial; alpha galactosidase
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 22-375-00; 58-5050-8-009 (Other Grant/Funding Number: USDA/ARS - Pulse Crop Health Initiative)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I am willing to share if I am asked about it. I do not plan to upload to a data repository at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No