Effect of Cheese on Cardiovascular Risk (ECCA)
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|ClinicalTrials.gov Identifier: NCT01739153|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : November 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemia||Other: Dietary intervention: CHEESE (High cheese intake) Other: Dietary intervention: MEAT (High Meat intake) Other: Dietary intervention: CARB (High Carbohydrate intake)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Cheese on Cardiovascular Risk|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||November 2014|
Experimental: CARB diet
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)|
Experimental: CHEESE diet
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)|
Experimental: MEAT diet
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)|
- LDL cholesterol [ Time Frame: day 1 and day 14 in each diet period ]fasting, mmol/l
- Blood lipid concentrations [ Time Frame: day 1 and day 14 in each diet period ]
Total cholesterol and HDL cholesterol. Fasting, mmol/l.
Triglycerides. Fasting and non-fasting, mmol/l
- ApoA1 and ApoB [ Time Frame: day 1 and day 14 in each diet period ]
- Dietary fat digestibility [ Time Frame: During day 10-14 in each period ]
Fecal fat and energy excretion.
Total excretion of fecal fat (grams/day) and energy (kJ/day) averaged over five days
- Blood pressure [ Time Frame: day 1 and day 14 in each diet period ]mmHg
- Anthropometry [ Time Frame: day 1 and day 14 in each diet period ]waist to hip ratio, waist circumference and body weight
- Insulin sensitivity [ Time Frame: day 1 and 14 in each diet period ]Fasting and non-fasting glucose and insulin
- Bile acid metabolism [ Time Frame: day 14 of each intervention period ]Serum alpha-HC, fecal bile acid excretion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739153
|Department of Nutrition, Exercise and Sports|
|Copenhagen, Frederiksberg, Denmark, 1958|
|Principal Investigator:||Arne Astrup, Prof, MD||Head of Department of Nutrition, Exercise and Sports|