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OpenTrials
Completed

NCT Number: NCT05537649

Glycemic Responses of an Innovative Oat Porridge

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oatmeal porridge

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.

Primary outcomes

  1. Glucose response

    Time frame: up to 3 hours

    incremental area under the curve of blood glucose after oat porridge consumption

Secondary outcomes

  1. Glucose response

    Time frame: up to 3 hours

    peak rise of the blood glucose after oat porridge consumption

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: GREAT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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