Effect of Cheese on Cardiovascular Risk (ECCA)

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Other: Dietary intervention: CARB (High Carbohydrate intake); Other: Dietary intervention: CHEESE (High cheese intake); Other: Dietary intervention: MEAT (High Meat intake)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg
    • Copenhagen, Frederiksberg, Denmark, 1958
      • Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Dairy Farmers of Canada; The Danish Dairy Research Foundation, Denmark; Dairy Research Institute; Centre National Interprofessionel de l'Economie Laitière; Dairy Australia; Nederlandse Zuivel Organisatie
• Investigators: Principal Investigator: Arne Astrup, Prof, MD, Head of Department of Nutrition, Exercise and Sports

Publications and helpful links

General Publications

• Thorning TK, Raziani F, Bendsen NT, Astrup A, Tholstrup T, Raben A. Diets with high-fat cheese, high-fat meat, or carbohydrate on cardiovascular risk markers in overweight postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2015 Sep;102(3):573-81. doi: 10.3945/ajcn.115.109116. Epub 2015 Jul 15.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Dairy; Cheese; Blood lipid concentrations; bile acids; Fecal fat; Blood lipid sizes; Fat digestibility
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: B302