Clinical trial NCT06005415: Glycemic Response to an Innovative Cookie to Promote Human Health
Official title: Glycemic Response to an Innovative Cookie to Promote Human Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glycemic Responses
Keywords: postprandial glycemic responses
gastric emptying rate
oral processing behavior
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

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

Primary outcomes:
measure: Glucose response
timeFrame: 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:
measure: Peak rise of blood glucose
timeFrame: 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
measure: Gastric emptying rate
timeFrame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 1
measure: Gastric emptying rate
timeFrame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 2
measure: Oral processing behavior (exposure time)
timeFrame: During test meal consumption, up to 10 minutes, on test day 1
measure: Oral processing behavior (exposure time)
timeFrame: During test meal consumption, up to 10 minutes, on test day 2
measure: Oral processing behavior (average bite size)
timeFrame: During test meal consumption, up to 10 minutes, on test day 1
measure: Oral processing behavior (average bite size)
timeFrame: During test meal consumption, up to 10 minutes, on test day 2
measure: Oral processing behavior (average chews per bite)
timeFrame: During test meal consumption, up to 10 minutes, on test day 1
measure: Oral processing behavior (average chews per bite)
timeFrame: During test meal consumption, up to 10 minutes, on test day 2
measure: Oral processing behavior (eating rate)
timeFrame: During test meal consumption, up to 10 minutes, on test day 1
measure: Oral processing behavior (eating rate)
timeFrame: During test meal consumption, up to 10 minutes, on test day 2
measure: Oral processing behavior (energy intake rate)
timeFrame: During test meal consumption, up to 10 minutes, on test day 1
measure: Oral processing behavior (energy intake rate)
timeFrame: During test meal consumption, up to 10 minutes, on test day 2
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke, Prof.
role: PRINCIPAL_INVESTIGATOR
References: