Employing dynamic kinetic responses to demonstrate the effectiveness of dietary intervention: A challenge-based study using a low-glycaemic load diet
- Conditions
- MetabolismThe metabolic process of the body
- Registration Number
- NL-OMON43816
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
- Signed informed consent
- Men and postmenopausal women: >= 50 and <= 70 years at the start of the study
- Body mass index (BMI) >= 25.0 and <= 35.0 kg/m2
- Healthy (as determined by dependent physician): no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases) as assessed by physical characteristics and health and lifestyle questionnaire
- Fasting blood glucose value <= 6.9 mmol/litre at screening
- Waist circumference >94 cm for males, >80 cm for females
- Maximum 2.5 hours of moderate to vigorous physical activity per week (during last 3 months)
- Agreeing to be informed about medically relevant personal test-results by a physician
- Willing to comply to study protocol during study
- Accessible veins on arms as determined by examination at screening
- Reported participation in another nutritional or biomedical trial three months before the pre- study examination or during the study
- Blood donation in the past three months
- Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM
- Consumption of > 21 alcoholic units for males, > 14 alcohol units for females in a typical week
- Reported use of any nicotine containing products in the six months preceding the study and during the study itself
- Reported dietary habits: medically prescribed diet, slimming diet, vegetarian
- People who are familiar with an allergy or intolerance to any of the provided food products
- Reported weight loss or weight gain (10%) in the last six months prior to the pre-study screening
- Clinically relevant abnormalities in clinical chemistry at screening (to be judged by the study physician)
- Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre (MUMC+)
- Taking medication, which may interfere with study measurements, as judged by the responsible physician
- Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Delta RQ (change in the mean RQ value) before (fasted state) and at the end<br /><br>of the 2.5-hour clamp period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters:<br /><br><br /><br>- Delta RQ (change in the mean RQ value) upon a mixed meal challenge<br /><br>- Phenotypic flexibility markers, clustered into markers for<br /><br>energy/carbohydrate metabolism, protein metabolism, lipid metabolism,<br /><br>inflammation and vascular function, upon a mixed meal challenge<br /><br>- Comparison of diet-induced changes in the kinetic response to diet-induced<br /><br>changes in the baseline value<br /><br>- Phenotypic flexibility markers, clustered into markers for<br /><br>energy/carbohydrate metabolism, protein metabolism, lipid metabolism,<br /><br>inflammation and vascular function, in the fasted state<br /><br>- Insulin sensitivity<br /><br><br /><br><br /><br>Other study parameters:<br /><br><br /><br>- Functional markers of cognitive and physical performance<br /><br>- Sleep quality, mood and quality of life<br /><br>- Body composition, 36-hour blood pressure, and 36-hour glycaemic response </p><br>