The effects of macronutrients on postprandial vascular function in overweight and slightly obese me
- Conditions
- Syndrome XInsulin Resistance SyndromeMetabolic Syndrome10013317
- Registration Number
- NL-OMON47116
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- Aged between 18-70 years
- Men
- BMI between 25-35 kg/m2 (overweight and slightly obese)
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Fasting serum triacylglycerol < 2.2 mmol/L
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- No current smoker
- No diabetic patients
- No familial hypercholesterolemia
- No abuse of drugs
- No more than 3 alcoholic consumptions per day
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- No use of medication known to treat blood pressure, lipid or glucose metabolism
- No use of an investigational product within another biomedical intervention trial within the previous 1-month
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- Women
- Fasting plasma glucose >= 7.0 mmol/L
- Fasting serum total cholesterol >= 8.0 mmol/L
- Fasting serum triacylglycerol >= 2.2 mmol/L
- Systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg
- Current smoker, or smoking cessation <12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use medication known to treat blood pressure, lipid or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measurements will be performed before and two hours after consumption of the<br /><br>milkshakes. The primary endpoint is the difference in postprandial change in<br /><br>FMD between the HF-LC-LP, LF-HC-LP and LF-LC-HP meal.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are the postprandial effects of a HF-LC-LP, LF-HC-LP and<br /><br>LF-LC-HP meal on other markers reflecting vascular function (PWA, PWV and<br /><br>retinal microvascular caliber), plasma markers for low-grade systemic<br /><br>inflammation and endothelial dysfunction, blood pressure, and serum lipid and<br /><br>plasma glucose metabolism.</p><br>