Glycemic Responses of an Innovative Oat Porridge (GREAT)

Catholic University (KU) of Leuven

Status

Completed

Conditions

Postprandial Glycemic Responses

Treatments

Dietary Supplement: Oatmeal porridge

Study type

Interventional

Funder types

Other

Identifiers

NCT05537649

S64889

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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