Effect of Cheese on Cardiovascular Risk (ECCA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Copenhagen
Sponsor:
Collaborators:
The Danish Dairy Research Foundation, Denmark
Dairy Research Institute
Dairy Farmers of Canada
Centre National Interprofessionel de l'Economie Laitière
Dairy Australia
Nederlandse Zuivel Organisatie
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01739153
First received: November 27, 2012
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention
Hyperlipidemia
Other: Dietary intervention: CHEESE (High cheese intake)
Other: Dietary intervention: MEAT (High Meat intake)
Other: Dietary intervention: CARB (High Carbohydrate intake)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Cheese on Cardiovascular Risk

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • LDL cholesterol [ Time Frame: day 1 and day 14 in each diet period ] [ Designated as safety issue: No ]
    fasting, mmol/l


Secondary Outcome Measures:
  • Blood lipid concentrations [ Time Frame: day 1 and day 14 in each diet period ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Dietary fat digestibility [ Time Frame: During day 10-14 in each period ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    mmHg

  • Anthropometry [ Time Frame: day 1 and day 14 in each diet period ] [ Designated as safety issue: No ]
    waist to hip ratio, waist circumference and body weight

  • Insulin sensitivity [ Time Frame: day 1 and 14 in each diet period ] [ Designated as safety issue: No ]
    Fasting and non-fasting glucose and insulin

  • Bile acid metabolism [ Time Frame: day 14 of each intervention period ] [ Designated as safety issue: No ]
    Serum alpha-HC, fecal bile acid excretion


Estimated Enrollment: 16
Study Start Date: January 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   45 Years to 68 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739153

Contacts
Contact: Tanja K Thorning, MSc +45 21305385 tkt@life.ku.dk
Contact: Nathalie T Bendsen, PhD nathalie@life.ku.dk

Locations
Denmark
Department of Nutrition, Exercise and Sports Recruiting
Copenhagen, Frederiksberg, Denmark, 1958
Contact: Tanja Kongerslev Thorning, MSc Human Nutrition    +45 21305385    tkt@life.ku.dk   
Contact: Nathalie Tommerup Bendsen, PhD       nathalie@life.ku.dk   
Principal Investigator: Arne Astrup, Prof, MD         
Sponsors and Collaborators
University of Copenhagen
The Danish Dairy Research Foundation, Denmark
Dairy Research Institute
Dairy Farmers of Canada
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
  More Information

No publications provided

Responsible Party: AAstrup, Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01739153     History of Changes
Other Study ID Numbers: B302
Study First Received: November 27, 2012
Last Updated: February 13, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Copenhagen:
Dairy
Cheese
Blood lipid concentrations
Blood lipid sizes
Fecal fat
Fat digestibility
bile acids

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014