Effects of C16:0 versus C18:0 on HDL metabolism and other cardiometabolic risk markers: A dietary intervention study in healthy normal-weight and overweight subjects
- Conditions
- MetabolismeHDL-metabolismrisk factors for cardiovascular disease
- Registration Number
- NL-OMON46224
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 43
- Apparently healthy men and post-menopausal women (post-menopausal for at least one year)
- BMI * 18.0 and * 30.0 kg/m2
- Age: 45-70 yrs
- Signed informed consent
- Having a medical condition which might impact study measurements
- Use of over-the-counter and prescribed medication, which may interfere with study measurements
- Use of oral antibiotics in 40 days or less prior to the start of the study;
- Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study;
- Reported alcohol consumption * 10 units/week (female) or * 14 units/week (male);
- Reported intense sporting activities * 10 hours/week;
- Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
- Regular smokers (at least one cigarette (or equivalent) daily or >7 cigarettes (or equivalent) weekly. Smokers who cannot comfortably restrain from smoking for up to 2 days will also be excluded
- Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
- Blood donation in the past 3 months
- Drug abuse
- Reported participation in another nutritional or biomedical trial 3 months prior to screening
- Fasting triacylglycerol concentrations at screening: * 4.5 mmol/L
- Serum lipids: treatment recommended according to the *Multidisciplinaire richtlijn Cardiovasculair risicomanagement*
- Fasting HbA1c * 48 mmol/mol (or 6.5%)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the change in HDL metabolism during the fasted<br /><br>state at the end of the dietary period high in palmitic acid versus the dietary<br /><br>period high in stearic acid.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are the effects of palmitic acid versus stearic acid<br /><br>on fasting LDL-C, HDL-C, total cholesterol, the total cholesterol to HDL-C<br /><br>ratio, the LDL-C to HDL-C ratio, non-HDL cholesterol, apoAI and apoB100, and on<br /><br>fasted and postprandial triacylglycerol concentrations.</p><br>