Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors
- Conditions
- Metabolic Syndrome
- Interventions
- Dietary Supplement: No-cheese/carbohydrateDietary Supplement: Low-fat cheeseDietary Supplement: High-fat cheese
- Registration Number
- NCT02616471
- Lead Sponsor
- University of Copenhagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No-cheese/carbohydrate group (CTR) No-cheese/carbohydrate For subjects in the CTR group, cheese is replaced by simple and starchy carbohydrates in jam and white bread, which will be supplied by the department. The daily energy and sodium contents will be matched to those of the cheese in the HFC group. No dairy/cheese consumption is allowed. Low-fat cheese (LFC) group Low-fat cheese The subjects in the LFC group will be supplied with equal amounts of two types of reduced/low fat cheeses. The cheeses are reduced-fat Danbo(Cheasy, 13% fat, Arla, DK) and reduced-fat Cheddar (Sharp Light Cheddar, 16% fat, Cabot, US). No further dairy/cheese consumption is allowed. High-fat cheese (HFC) group High-fat cheese The subjects in the HFC group will be supplied with equal amounts of two types of regular/high fat cheeses. The cheeses are normal-fat Danbo (Riberhus, 25% fat, Arla, DK) and normal-fat Cheddar (Sharp Cheddar, 32% fat, Cabot, US). No further dairy and cheese consumption is allowed
- Primary Outcome Measures
Name Time Method Changes in LDL cholesterol from baseline to post-intervention week 1 and week 12 fasting, mmol/l
- Secondary Outcome Measures
Name Time Method Particle size week 1 and week 12 HDL, VLDL and LDL particle size (by NMR)
Blood lipid concentrations week 1 and week 12 Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l)
Anthropometry 5 times during the 12-week intervention Hip circumference (cm) Waist circumference (cm) Weight (kg)
Postprandial appetite sensation (by VAS) week 12 Measurements in a sub-group
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)
Inflammation week 1 and week 12 Serum C-reactive protein - 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
Trial Locations
- Locations (1)
Department of Nutrition, Exercise and Sport
🇩🇰Copenhagen, Frederiksberg, Denmark