Glycemic Response of Whole Beans and Bean Products

NCT06630312 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 22-375-0058-5050-8-009
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Body Mass Index, Normal; Postprandial Hyperglycemia

Keywords

Normoglycemia; Glucose, postprandial; Insulin; alpha galactosidase; young adults

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose

  Venous blood sample of glucose

  Time 0 (fasting), then every 30 minutes for 3 hours

Secondary Outcomes (5)

• Postprandial insulin

  Time 0 (fasting), then every 30 minutes for 3 hours

• Postprandial triglycerides

  Time 0 (fasting), then every 60 minutes for 3 hours

• Satiety or Appetite evaluation

  Time 0 (fasting), then 45 minutes post-ingestion, and 30 minutes after that for seven data points

• Breath hydrogen

  Time 0 (fasting), then every 15 minutes for 3 hours

• Gastrointestinal symptoms

  Pre-test day, evening of testing in the am, and evening on the day after testing

Study Arms (4)

Yellow beans

PLACEBO COMPARATOR

Yellow beans, cooked in spaghetti sauce

Dietary Supplement: Placebo

Yellow beans with AGS

EXPERIMENTAL

Yellow beans, cooked in spaghetti sauce, with AGS treatment

Dietary Supplement: Alpha galactosidase

Yellow bean pasta

PLACEBO COMPARATOR

Yellow bean pasta with spaghetti sauce

Dietary Supplement: Placebo

Yellow bean pasta with AGS

EXPERIMENTAL

Dietary Supplement: Alpha galactosidase

Interventions

Alpha galactosidase DIETARY_SUPPLEMENT

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.

Also known as: Beano

Yellow bean pasta with AGS; Yellow beans with AGS

Placebo DIETARY_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.

Yellow bean pasta; Yellow beans

Eligibility Criteria

• Age: 21 Years - 34 Years
• Gender Eligibility Details: Men, Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Interventions

alpha-Galactosidase

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: March 28, 2023
• Primary Completion: June 27, 2023
• Study Completion: October 17, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

US (1)