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

Catholic University (KU) of Leuven

Status: Completed

Conditions: Postprandial Glycemic Responses

Treatments: Dietary Supplement: Wire-cut cookie

Study type: Interventional

Funder types: Other

Identifiers

NCT06005415

S67376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Test cookie

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Wire-cut cookie

Control cookie

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Wire-cut cookie