Status:
COMPLETED
Glycemic Response to an Innovative Cookie to Promote Human Health
Lead Sponsor:
KU Leuven
Conditions:
Postprandial Glycemic Responses
Eligibility:
All Genders
18-50 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06005415
Start Date
September 5 2023
End Date
November 24 2023
Last Update
November 29 2023
Active Locations (1)
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1
KU Leuven/UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000