Postprandial Glycemic ResponsesGREATNCT05537649
Glycemic Responses of an Innovative Oat Porridge
A study testing Oatmeal porridge in people with Postprandial Glycemic Responses, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycemic Responses
- What is being tested?
- Oatmeal porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jun 2021to 8 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Oatmeal porridge
- Keywords
- enzymatic starch modification, postprandial glycemic responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oatmeal porridge | Active comparator | Cold-stored oatmeal porridge (38 g oats) and stored for 24 h at 4 degrees Celsius Receives: 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 Receives: Dietary Supplement: Oatmeal porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response
incremental area under the curve of blood glucose after oat porridge consumption
Measured: up to 3 hours
Secondary outcomes (1)
Glucose response
peak rise of the blood glucose after oat porridge consumption
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start23 Jun 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Glycemic ResponsesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537649
- Sponsor's protocol ID
- S64889
- Acronym
- GREAT
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Responses of an Innovative Oat Porridge
- ClinicalTrials.gov ID
- NCT05537649
- Acronym / sponsor ID
- GREAT / S64889
- Conditions
- Postprandial Glycemic Responses
- Keywords
- enzymatic starch modification, postprandial glycemic responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oatmeal porridge | Active comparator | Dietary Supplement: Oatmeal porridgeCold-stored oatmeal porridge (38 g oats) and stored for 24 h at 4 degrees Celsius |
| Oatmeal porridge treated with amylomaltase | Active comparator | Dietary Supplement: Oatmeal porridgeCold-stored oatmeal porridge (38 g oats) treated with 30 enzyme units/g oats of amylomaltase and stored for 24 h at 4 degrees Celsius |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oatmeal porridgeInvestigation of the impact of enzymatic modification of the molecular structure of starch by amylomaltase on the postprandial glycemic responses of an oatmeal porridge. | Dietary supplement | Oatmeal porridge, Oatmeal porridge treated with amylomaltase |
Primary outcome
Glucose response
Time frame: up to 3 hours
incremental area under the curve of blood glucose after oat porridge consumption
1 secondary outcome
Glucose response
Time frame: up to 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oatmeal porridge in people with Postprandial Glycemic Responses, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose response (time frame: up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.