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Effect of Cheese on Cardiovascular Risk (ECCA)

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dietary intervention: CHEESE (High cheese intake)
Dietary intervention: MEAT (High Meat intake)
Dietary intervention: CARB (High Carbohydrate intake)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia focused on measuring Dairy, Cheese, Blood lipid concentrations, Blood lipid sizes, Fecal fat, Fat digestibility, bile acids

Eligibility Criteria

45 Years - 68 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CARB diet

CHEESE diet

MEAT diet

Arm 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%).

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).

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).

Outcomes

Primary Outcome Measures

LDL cholesterol
fasting, mmol/l

Secondary Outcome Measures

Blood lipid concentrations
Total cholesterol and HDL cholesterol. Fasting, mmol/l. Triglycerides. Fasting and non-fasting, mmol/l
ApoA1 and ApoB
Dietary fat digestibility
Fecal fat and energy excretion. Total excretion of fecal fat (grams/day) and energy (kJ/day) averaged over five days
Blood pressure
mmHg
Anthropometry
waist to hip ratio, waist circumference and body weight
Insulin sensitivity
Fasting and non-fasting glucose and insulin
Bile acid metabolism
Serum alpha-HC, fecal bile acid excretion

Full Information

First Posted
November 27, 2012
Last Updated
November 20, 2014
Sponsor
University of Copenhagen
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
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1. Study Identification

Unique Protocol Identification Number
NCT01739153
Brief Title
Effect of Cheese on Cardiovascular Risk
Acronym
ECCA
Official Title
Effect of Cheese on Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Dairy, Cheese, Blood lipid concentrations, Blood lipid sizes, Fecal fat, Fat digestibility, bile acids

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CARB diet
Arm Type
Experimental
Arm 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%).
Arm Title
CHEESE diet
Arm Type
Experimental
Arm 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).
Arm Title
MEAT diet
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
Dietary intervention: CHEESE (High cheese intake)
Intervention Type
Other
Intervention Name(s)
Dietary intervention: MEAT (High Meat intake)
Intervention Type
Other
Intervention Name(s)
Dietary intervention: CARB (High Carbohydrate intake)
Primary Outcome Measure Information:
Title
LDL cholesterol
Description
fasting, mmol/l
Time Frame
day 1 and day 14 in each diet period
Secondary Outcome Measure Information:
Title
Blood lipid concentrations
Description
Total cholesterol and HDL cholesterol. Fasting, mmol/l. Triglycerides. Fasting and non-fasting, mmol/l
Time Frame
day 1 and day 14 in each diet period
Title
ApoA1 and ApoB
Time Frame
day 1 and day 14 in each diet period
Title
Dietary fat digestibility
Description
Fecal fat and energy excretion. Total excretion of fecal fat (grams/day) and energy (kJ/day) averaged over five days
Time Frame
During day 10-14 in each period
Title
Blood pressure
Description
mmHg
Time Frame
day 1 and day 14 in each diet period
Title
Anthropometry
Description
waist to hip ratio, waist circumference and body weight
Time Frame
day 1 and day 14 in each diet period
Title
Insulin sensitivity
Description
Fasting and non-fasting glucose and insulin
Time Frame
day 1 and 14 in each diet period
Title
Bile acid metabolism
Description
Serum alpha-HC, fecal bile acid excretion
Time Frame
day 14 of each intervention period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Prof, MD
Organizational Affiliation
Head of Department of Nutrition, Exercise and Sports
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26178720
Citation
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.
Results Reference
derived

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Effect of Cheese on Cardiovascular Risk

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