NCT05537649

Completed

Glycemic Responses of an Innovative Oat Porridge

KU Leuven Source

Other study identifiers

Sponsor study identifier

S64889

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

June 23, 2021

Actual (reported)

Primary Completion

October 8, 2021

Actual (reported)

Study Completion

October 8, 2021

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: October 8, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 23, 2021
Actual (reported)
Primary Completion
October 8, 2021
Actual (reported)
Study Completion
October 8, 2021
Actual (reported)
First Submitted
September 8, 2022
Actual (reported)
First Posted
September 13, 2022
Actual (reported)

Last Updated: September 13, 2022
Status Verified: September 2022
Last Update Submitted: September 8, 2022

Conditions

Postprandial Glycemic Responses

Keywords

enzymatic starch modificationpostprandial glycemic responses

Outcome Measures

Primary Outcomes (1)

Glucose response
incremental area under the curve of blood glucose after oat porridge consumption
up to 3 hours

Secondary Outcomes (1)

Glucose response
up to 3 hours

Study Arms (2)

Oatmeal porridge

ACTIVE COMPARATOR

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

Dietary Supplement: Oatmeal porridge

Oatmeal porridge treated with amylomaltase

ACTIVE COMPARATOR

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

Interventions

Oatmeal porridgeDietary 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 porridgeOatmeal porridge treated with amylomaltase

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit
Fasting whole blood glucose values \< 6.3 mmol/L

Sponsors & Collaborators

KU Leuven
Otherlead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

June 23, 2021

Actual (reported)

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

October 8, 2021

Actual (reported)

Study Completion

October 8, 2021

Actual (reported)

Last Updated

September 13, 2022

Record last verified: 2022-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05537649
Data provider: ClinicalTrials.gov
Source updated: 2022-09-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:08 UTC

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Oatmeal porridge

Oatmeal porridge treated with amylomaltase

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations