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Glycemic Response of Whole Beans and Bean Products

NCT06630312 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-08

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Iowa State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
34 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2023-06-27
Completion
2023-10-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630312 on ClinicalTrials.gov