Metabolic Syndrome, Syndrome X, Insulin Resistance Syndrome Metabool Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Men and postmenopausal women (= 2 years since last menstruation);Aged between 40-75 years;BMI between 25-35 kg/m2 (overweight or obese);Low-to-moderate habitual dairy consumption (= 3 servings/day);Fasting serum total cholesterol < 8.0 mmol/L;Fasting serum triacylglycerol < 4.5 mmol/L;Fasting plasma glucose < 7.0 mmol/L;Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg;Stable body weight (weight gain or loss < 3 kg in the past three months).
Exclusion criteria
Exclusion criteria: Left-handedness;Milk protein allergy or lactose intolerance; Current smoker, or smoking cessation < 12 months;Familial hypercholesterolemia;Abuse of drugs;Alcoholic intake >3 standard drinks/day;Use of medications, food products or dietary supplements affecting glucose, lipid, or blood pressure regulation, gut microbiota or mental or neurological function, judged by the principal investigator;Use of antibiotics within the previous month;Use of other biomedical investigational products within the previous month;Participation in another clinical trial within the past month;Severe medical conditions including type 2 diabetes, epilepsy, asthma, kidney failure, COPD, inflammatory bowel disease, autoimmune diseases, or rheumatoid arthritis;History of cardiovascular events (e.g., heart attack, stroke) or active cardiovascular disease;Contra-indications for MRI imaging (e.g. pacemaker, metal implants, claustrophobia);Willingness to not donate blood starting from 8 weeks before the study begins, throughout the study, and for 4 weeks after its inclusion;No difficult venipuncture as evidenced during the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is effect of a high-dairy food pattern as compared with a low-dairy food pattern on (regional) brain vascular function and insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered insulin using MRI ASL. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include changes in cognitive performance (via the CANTAB neuropsychological test battery), gut microbiota composition (via shotgun metagenomic analysis of fecal samples), and appetite-related brain reward activity (via BOLD-fMRI with food cues). | — |
Countries
Netherlands
Contacts
Universiteit Maastricht