Glycemic Responses of an Innovative Oat Porridge (GREAT)

The aim of this study is to investigate whether enzymatic modification of starch in a food product using amylomaltase induces a lower glycemic response in healthy subjects compared to its unmodified counterpart.

Study Overview

• Status: Completed
• Conditions: Postprandial Glycemic Responses
• Intervention / Treatment: Dietary supplement: Oatmeal porridge

Detailed Description

A single-blind, randomized, cross-over study design will be applied. During each of the two study visits, healthy participants will consume an oatmeal porridge. One porridge will be treated will amylomaltase to modify the molecular structure of starch while the other porridge will serve as a control (unmodified counterpart). Blood glucose measurements will be taken postprandially at regular time points.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit
• Fasting whole blood glucose values < 6.3 mmol/L
• Regular diet with 3 meals a day (at least 5 times a week)
• Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigators on the basis of medical history
• Willingness to maintain habitual diet, physical activity pattern, and body weight throughout the trial and refrain from smoking for 12 h prior to each visit
• Willingness to abstain from alcohol consumption and to avoid vigorous physical activity for 24 h prior to study visits.
• Adequate level of understanding spoken and written English
• Willingness to provide informed consent to participate in the study

Exclusion Criteria:

• Failure to meet any one of the inclusion criteria
• Recent participation in any clinical trial (< 90 days)
• Pregnant or lactating in the period of the study
• Known history of AIDS, hepatitis, diabetes mellitus (Type I and II), cardiovascular disease, any pathology (or recent surgical event) of the gastrointestinal system or any current metabolic or endocrine disease
• Alcohol consumption of > 14 standard drinks for women and > 21 standard drinks for men per week
• Celiac disease or gluten intolerance
• Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids the last 4 weeks before the screening visit
• Use of antibiotics during the last three months
• Reported slimming or medically prescribed diet
• Unwillingness or inability to comply with the experimental procedures and to follow the safety guidelines

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oatmeal porridge; Cold-stored oatmeal porridge (38 g oats) and stored for 24 h at 4 degrees Celsius	Dietary supplement: Oatmeal porridge; Investigation of the impact of enzymatic modification of the molecular structure of starch by amylomaltase on the postprandial glycemic responses of an oatmeal porridge.
Active Comparator: Oatmeal porridge treated with amylomaltase; Cold-stored oatmeal porridge (38 g oats) treated with 30 enzyme units/g oats of amylomaltase and stored for 24 h at 4 degrees Celsius	Dietary supplement: Oatmeal porridge; Investigation of the impact of enzymatic modification of the molecular structure of starch by amylomaltase on the postprandial glycemic responses of an oatmeal porridge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose response	incremental area under the curve of blood glucose after oat porridge consumption	up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose response	peak rise of the blood glucose after oat porridge consumption	up to 3 hours

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: enzymatic starch modification; postprandial glycemic responses
• Other Study ID Numbers: S64889

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No