Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

Study Overview
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Brief Summary
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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.

Official Title
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Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors in a Metabolically Vulnerable Population

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: High-fat cheese
* Dietary Supplement: Low-fat cheese
* Dietary Supplement: No-cheese/carbohydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-fat cheese (HFC) group<br>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 | Dietary Supplement: High-fat cheese<br> <br> |
| Experimental: Low-fat cheese (LFC) group<br>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. | Dietary Supplement: Low-fat cheese<br> <br> |
| Active Comparator: No-cheese/carbohydrate group (CTR)<br>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. | Dietary Supplement: No-cheese/carbohydrate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in LDL cholesterol from baseline to post-intervention | fasting, mmol/l | week 1 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid concentrations | Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l) | week 1 and week 12 | 
| Particle size | HDL, VLDL and LDL particle size (by NMR) | week 1 and week 12 | 
| Anthropometry | Hip circumference (cm) Waist circumference (cm) Weight (kg) | 5 times during the 12-week intervention | 
| Blood pressure (BP) | Systolic BP (mmHG) Diastolic BP (mmHG) | 3 time during the 12-week intervention | 
| Insulin sensitivity | Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l) | week 1 and week 12 | 
| Inflammation | Serum C-reactive protein - fasting (mmol/l) | week 1 and week 12 | 
| Postprandial markers of lipid metabolism | Measurements in a sub-group | week 12 | 
| Postprandial markers of glucose metabolism | Measurements in a sub-group | week 12 | 
| Postprandial appetite sensation (by VAS) | Measurements in a sub-group | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cheese, Dairy, Saturated fat, Blood lipid concentrations, Lipoprotein particle size, Metabolic Syndrome, Insulin sensitivity, Blood glucose concentrations