Effect of Cheese on Cardiovascular Risk

Study Overview
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Brief Summary
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The main objective of the current study is to examine whether a high intake of regular-fat cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin sensitivity is investigated. To do this, a randomized crossover intervention study with 3x14 days full diet periods (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between the diet periods there will be at least 14 days of wash-out where the subjects eat their habitual diets. Fasting blood samples will be drawn before and after the diet periods, and also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total feces is collected the last 5 days of each diet period.

Official Title
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Effect of Cheese on Cardiovascular Risk

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Other: Dietary intervention: CHEESE (High cheese intake)
* Other: Dietary intervention: MEAT (High Meat intake)
* Other: Dietary intervention: CARB (High Carbohydrate intake)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Postmenopausal for >1 year Age 45-68 years BMI 25-32 kg/m2 TC > 4.5 mmol/L and < 7 mmol/L Systolic blood pressure <160 mmHg and/or diastolic blood pressure <100 mmHg Exclusion Criteria: Chronic diseases (known diabetes; CVD; other chronic diseases which could affect the results of the present study) Milk allergy Nut allergy Use of dietary supplements incl. multivitamins (2 months before and during the entire study period) Smoking Elite athletes (>10 hours of strenuous physical activity per week) Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids Use of lipid-lowering agents Stable dose of antihypertensive medication >3 months before study commencement for subjects with high blood pressure Hormone replacement therapy Blood donation <1 month before study commencement and during study period Simultaneous participation in other clinical studies Inability (physically or psychologically) to comply with the procedures required by the protocol

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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Female

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARB diet<br>The CARB diet will be a low-fat diet where cheese is replaced by starchy carbohydrates and lean meat. The CARB diet will have the same protein content (15 E%) and quality as the CHEESE and MEAT diet but a lower fat content (approx. 25 E%) and a correspondingly higher carbohydrate content (approx. 60 E%). | Other: Dietary intervention: CARB (High Carbohydrate intake)<br> <br> |
| Experimental: CHEESE diet<br>The CHEESE diet will contain cheese in amounts corresponding to 120 g/day on a 10 MJ diet (approx. 1.8 MJ from cheese). A high dose of cheese is chosen to provoke effects within this short time frame. The cheese types used in this study will be Danbo (45+) and Cheddar (50+) which will be supplied in equal amounts. The CHEESE diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat). | Other: Dietary intervention: CHEESE (High cheese intake)<br> <br> |
| Experimental: MEAT diet<br>The MEAT diet will be a diet without dairy products. In this diet cheese is mainly replaced by high-fat mixed meat products to achieve saturated fat content and protein quality similar to that of the CHEESE diet. The MEAT diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat). | Other: Dietary intervention: MEAT (High Meat intake)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol | fasting, mmol/l | day 1 and day 14 in each diet period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid concentrations | Total cholesterol and HDL cholesterol. Fasting, mmol/l. Triglycerides. Fasting and non-fasting, mmol/l | day 1 and day 14 in each diet period | 
| ApoA1 and ApoB |  | day 1 and day 14 in each diet period | 
| Dietary fat digestibility | Fecal fat and energy excretion. Total excretion of fecal fat (grams/day) and energy (kJ/day) averaged over five days | During day 10-14 in each period | 
| Blood pressure | mmHg | day 1 and day 14 in each diet period | 
| Anthropometry | waist to hip ratio, waist circumference and body weight | day 1 and day 14 in each diet period | 
| Insulin sensitivity | Fasting and non-fasting glucose and insulin | day 1 and 14 in each diet period | 
| Bile acid metabolism | Serum alpha-HC, fecal bile acid excretion | day 14 of each intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dairy, Cheese, Blood lipid concentrations, Blood lipid sizes, Fecal fat, Fat digestibility, bile acids