Effect of Cheese on Cardiovascular Risk (ECCA)

University of Copenhagen

Status: Completed

Conditions: Hyperlipidemia

Treatments: Other: Dietary intervention: CARB (High Carbohydrate intake); Other: Dietary intervention: CHEESE (High cheese intake); Other: Dietary intervention: MEAT (High Meat intake)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01739153

B302

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Female

Ages: 45 to 68 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

CARB diet

Experimental group

Description:

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%).

Treatment:

Other: Dietary intervention: CARB (High Carbohydrate intake)

CHEESE diet

Experimental group

Description:

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).

Treatment:

Other: Dietary intervention: CHEESE (High cheese intake)

MEAT diet

Experimental group

Description:

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).

Treatment:

Other: Dietary intervention: MEAT (High Meat intake)