Postprandial Glycemic ResponsesGRINCHNCT06005415
Glycemic Response to an Innovative Cookie to Promote Human Health
A study testing Wire-cut cookie 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 using a coarse wheat fraction in wire-cut cookie making induces a lower glycemic response in healthy subjects compared to wheat flour. 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?
- Wire-cut cookie
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Sep 2023to 24 Nov 2023
- 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
- Willingness to abstain from alcohol consumption and to avoid vigorous physical activity for 24 h prior to study visits
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- Adequate level of understanding spoken and written English
- Willingness to report lifestyle factors such as level of physical activity and perceived psychological stress
- 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 or wishing to become pregnant 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
- Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate whether using a coarse wheat fraction in wire-cut cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.
Read the detailed description
This study has a double-blind, randomized, cross-over design. During each of the two study visits, healthy participants will consume a standard portion of cookies. One cookie formulation will present a large amount of coarse wheat fraction, while the other formulation will include only wheat flour and will serve as a control. Blood glucose measurements will be taken postprandially at regular time points. Gastric emptying rate and oral processing behavior will be also object of study.
- Conditions
- Postprandial Glycemic Responses
- Being tested
- Wire-cut cookie
- Keywords
- postprandial glycemic responses, gastric emptying rate, oral processing behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wire-cut cookieDietary supplement
Investigation of the impact of wheat particle size on the postprandial glycemic response, gastric emptying and oral processing behavior after consumption of wire-cut cookies.
| Study group | Role | What they receive |
|---|---|---|
| Test cookie | Active comparator | Wire-cut cookie portion (85 g) containing wheat flour, coarse wheat semolina, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate. Receives: Dietary Supplement: Wire-cut cookie |
| Control cookie | Active comparator | Wire-cut cookie portion (85 g) containing wheat flour, wheat bran, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate. Receives: Dietary Supplement: Wire-cut cookie |
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 concentration (mM) after wheat-based wire-cut cookie consumption, measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).
Measured: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2
Secondary outcomes (13)
Peak rise of blood glucose
Difference between the highest postprandial blood glucose concentration and the baseline (expressed in mM), measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).
Measured: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2
Gastric emptying rate
Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).
Measured: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 1
Gastric emptying rate
Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).
Measured: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 2
Oral processing behavior (exposure time)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).
Measured: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (exposure time)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).
Measured: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (average bite size)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).
Measured: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (average bite size)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).
Measured: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (average chews per bite)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.
Measured: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (average chews per bite)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.
Measured: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (eating rate)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).
Measured: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (eating rate)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).
Measured: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (energy intake rate)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).
Measured: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (energy intake rate)
Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).
Measured: During test meal consumption, up to 10 minutes, on test day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start5 Sep 2023
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
- Investigators
- Kristin Verbeke, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005415
- Sponsor's protocol ID
- S67376
- Acronym
- GRINCH
- Status last verified
- Nov 2023
- First submitted
- 1 Aug 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Response to an Innovative Cookie to Promote Human Health
- ClinicalTrials.gov ID
- NCT06005415
- Acronym / sponsor ID
- GRINCH / S67376
- Conditions
- Postprandial Glycemic Responses
- Keywords
- postprandial glycemic responses, gastric emptying rate, oral processing behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 22 Aug 2023 (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 using a coarse wheat fraction in wire-cut cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.
Detailed description
This study has a double-blind, randomized, cross-over design. During each of the two study visits, healthy participants will consume a standard portion of cookies. One cookie formulation will present a large amount of coarse wheat fraction, while the other formulation will include only wheat flour and will serve as a control. Blood glucose measurements will be taken postprandially at regular time points. Gastric emptying rate and oral processing behavior will be also object of study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test cookie | Active comparator | Dietary Supplement: Wire-cut cookieWire-cut cookie portion (85 g) containing wheat flour, coarse wheat semolina, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate. |
| Control cookie | Active comparator | Dietary Supplement: Wire-cut cookieWire-cut cookie portion (85 g) containing wheat flour, wheat bran, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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
Key exclusion criteria (11 listed)
- Failure to meet any one of the inclusion criteria
- Recent participation in any clinical trial (< 90 days)
- Pregnant or lactating or wishing to become pregnant 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 |
|---|---|---|
| Wire-cut cookieInvestigation of the impact of wheat particle size on the postprandial glycemic response, gastric emptying and oral processing behavior after consumption of wire-cut cookies. | Dietary supplement | Control cookie, Test cookie |
Primary outcome
Glucose response
Time frame: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2
Incremental area under the curve of blood glucose concentration (mM) after wheat-based wire-cut cookie consumption, measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).
13 secondary outcomes
Peak rise of blood glucose
Time frame: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2
Gastric emptying rate
Time frame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 1
Gastric emptying rate
Time frame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 2
Oral processing behavior (exposure time)
Time frame: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (exposure time)
Time frame: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (average bite size)
Time frame: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (average bite size)
Time frame: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (average chews per bite)
Time frame: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (average chews per bite)
Time frame: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (eating rate)
Time frame: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (eating rate)
Time frame: During test meal consumption, up to 10 minutes, on test day 2
Oral processing behavior (energy intake rate)
Time frame: During test meal consumption, up to 10 minutes, on test day 1
Oral processing behavior (energy intake rate)
Time frame: During test meal consumption, up to 10 minutes, on test day 2
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 29 Nov 2023.
- Individual participant dataSharing planned: No
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SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
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A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
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Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms
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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.
Kristin Verbeke, Prof. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wire-cut cookie 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 9 inclusion and 11 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 29 Nov 2023. 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: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2). 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 29 Nov 2023.