Glycemic Responses of an Innovative Oat Porridge

NCT ID: NCT05537649

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2021-10-08

Brief Summary

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.

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.

Conditions

Postprandial Glycemic Responses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Oatmeal porridge

Cold-stored oatmeal porridge (38 g oats) and stored for 24 h at 4 degrees Celsius

Group Type: ACTIVE_COMPARATOR

Oatmeal porridge

Intervention Type: DIETARY_SUPPLEMENT

Investigation of the impact of enzymatic modification of the molecular structure of starch by amylomaltase on the postprandial glycemic responses of an oatmeal porridge.

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

Group Type: ACTIVE_COMPARATOR

Oatmeal porridge

Intervention Type: DIETARY_SUPPLEMENT

Investigation of the impact of enzymatic modification of the molecular structure of starch by amylomaltase on the postprandial glycemic responses of an oatmeal porridge.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Kristin Verbeke

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

S64889

Identifier Type: -

Identifier Source: org_study_id