Glycemic Response to an Innovative Cookie to Promote Human Health (GRINCH)

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Glycemic Responses
• Intervention / Treatment: Dietary supplement: Wire-cut cookie

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven/UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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
• 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 report lifestyle factors such as level of physical activity and perceived psychological stress
• 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 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test cookie; Wire-cut cookie portion (85 g) containing wheat flour, coarse wheat semolina, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate.	Dietary supplement: Wire-cut cookie; 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.
Active Comparator: Control cookie; Wire-cut cookie portion (85 g) containing wheat flour, wheat bran, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate.	Dietary supplement: Wire-cut cookie; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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.	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.	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).	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).	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).	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).	During test meal consumption, up to 10 minutes, on test day 2

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Kristin Verbeke, Prof., KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): November 24, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: postprandial glycemic responses; gastric emptying rate; oral processing behavior
• Other Study ID Numbers: S67376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No