'Lipid metabolism' and 'postprandial lipemia'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Apparently healthy men and women as judged by study physician * Abdominally obese males (waist circumference * 102 cm) and females (waist circumference * 88 cm) * Aged between 18 * 75 years * Stable bodyweight (weight gain or loss * 3 kg in the past three months) * Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study * Women should be pre- or postmenopausal * No difficult venipuncture as evidenced during the screening visit * Sedentary (light exercise
Exclusion criteria
Exclusion criteria: * Fasting plasma glucose * 7 mmol/l * Fasting serum triacylglycerol * 4.5 mmol/l * Fasting serum total cholesterol * 8 mmol/l * Blood pressure * 160/100 mm Hg * Current smoker, or smoking cessation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the difference in the area under the curve (AUC) for TAG after a mixed meal challenge between the end of the 4- week alternating and regular eating schedules. Secondary endpoints include fasting lipid metabolism, fasting glucose metabolism, and postprandial glycaemic responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose metabolism: - Fasting glucose, insulin, and C-peptide concentrations From the CGM: - The total area under the curve (tAUC) for 24-hour glucose, day-time glucose (07:00 am * 22:00 pm), and night-time glucose (22:01 pm * 06:59 am). - The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) - The mean amplitude of glycemic excursions (MAGE) as parameter for the assessment of glycemic variability. - Continuous overall net glycemic action (CONGA) to assess intraday glucose variability within predetermined time windows -> 1-hour interval (CONGA-1), 2-hour interval (CONGA-2), and 4-hour interval (CONGA-4). From the mixed meal (postprandial responses): - TAG iAUC, maximal increase TAG, time to peak TAG - NEFA AUC, NEFA dAUC, maximal decrease NEFA, time to nadir NEFA - Glucose AUC, glucose iAUC, maximal increase glucose, time to peak glucose - Insulin AUC, insulin iAUC, maximal increase insulin, time to peak insulin - C-peptide AUC, C-peptide iAUC, maximal increase C-peptide, time to peak C-peptide Lipid metabolism: - Fasting serum lipid and lipoprotein profile (TC, HDL-C, LDL-C, TAG) - Fasting serum non-cholesterol sterols as markers for intestinal cholesterol absorption (campesterol, sitosterol, cholestanol) and endogenous cholesterol synthesis (lathosterol and desmosterol) | — |
Countries
Netherlands