Glycemic Response to an Innovative Cookie to Promote Human Health

NCT ID: NCT06005415

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-05
• Study Completion Date: 2023-11-24

Brief 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.

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

Keywords

postprandial glycemic responses; gastric emptying rate; oral processing behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Wire-cut cookie

Intervention Type: DIETARY_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.

Control cookie

Wire-cut cookie portion (85 g) containing wheat flour, wheat bran, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate.

Group Type: ACTIVE_COMPARATOR

Wire-cut cookie

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Kristin Verbeke

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Verbeke, Prof.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven/UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

S67376

Identifier Type: -

Identifier Source: org_study_id