Metabolic Syndrome
Conditions
Keywords
Cheese, Dairy, Saturated fat, Blood lipid concentrations, Lipoprotein particle size, Metabolic Syndrome, Insulin sensitivity, Blood glucose concentrations
Brief summary
The overall aim of the present research project is to examine whether consumption of high daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a study population of men and women with metabolic syndrome risk factors. It will be explored whether high-fat and/or low-fat cheese consumption can be regarded healthy to consume for at-risk populations (assessed by within-group comparisons from baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to be recommended (assessed by between-group comparisons). In addition, it will be assessed if cheese consumption affects women and men differently as suggested by observational data. The present research project will examine the health effects of cheese as a food product per se and not as a sum of single nutrients, knowing that the single components of cheese cannot be adequately placebo-matched. A relatively high daily intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a carbohydrate control.
Interventions
DIETARY_SUPPLEMENTHigh-fat cheese
DIETARY_SUPPLEMENTLow-fat cheese
DIETARY_SUPPLEMENTNo-cheese/carbohydrate
Sponsors
The Danish Dairy Research Foundation, Denmark
Dairy Research Institute
Dairy Farmers of Canada
Centre National Interprofessionel de l'Economie Laitière
Dairy Australia
Nederlandse Zuivel Organisatie
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Men or women Age 18-70 Waist circumference \> 80 cm for women / \> 94 cm for men Plus at least one additional established risk factor for the metabolic syndrome using the following criteria: * Elevated BP (Systolic BP \> 130 mmHg and/or diastolic BP \> 85 mmHg); * Elevated triglycerides (\>1.7 mmol/l); * Reduced HDL-C (\<1.0 mmol/l for men and \< 1.3 mmol/l for women); * Elevated fasting glucose (\> 5.6 mmol/l). BMI 18.5 - 35 kg/m2
Exclusion criteria
Chronic diseases (known diabetes; cardiovascular disease; other chronic diseases which could affect the results of the present study) Milk allergy Use of dietary supplements incl. multivitamins (2 months before and during the entire study period) \>10 hours of strenuous physical activity per week Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids or medicine which have interactions with the intervention products (safety) Drug or alcohol abuse Blood donation \<1 month before study commencement and during study period Simultaneous participation in other clinical studies Pregnant or lactating women, or women who are planning to become pregnant within the next 6 months. Inability to comply with the procedures required by the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in LDL cholesterol from baseline to post-intervention | week 1 and week 12 | fasting, mmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Particle size | week 1 and week 12 | HDL, VLDL and LDL particle size (by NMR) |
| Anthropometry | 5 times during the 12-week intervention | Hip circumference (cm) Waist circumference (cm) Weight (kg) |
| Blood pressure (BP) | 3 time during the 12-week intervention | Systolic BP (mmHG) Diastolic BP (mmHG) |
| Insulin sensitivity | week 1 and week 12 | Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l) |
| Blood lipid concentrations | week 1 and week 12 | Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l) |
| Postprandial markers of lipid metabolism | week 12 | Measurements in a sub-group |
| Postprandial markers of glucose metabolism | week 12 | Measurements in a sub-group |
| Postprandial appetite sensation (by VAS) | week 12 | Measurements in a sub-group |
| Inflammation | week 1 and week 12 | Serum C-reactive protein - fasting (mmol/l) |
Countries
Denmark
Outcome results
None listed