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Study of the Impact of Dairy Fat on Cardiovascular Health. (HDL)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cheese diet
Butter diet
CHO diet
MUFA diet
PUFA diet
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women age between 18 and 65 years
  • Waist circumference >80.0 cm for women and >94.0 cm for men
  • Plasma concentration of triglycerides >1.70 mmol / L
  • Stable weight for 6 months before the start of the study (+/- 5lbs)

Exclusion Criteria:

  • Men or women aged under 18 years or over 65 years
  • History of CVD, type 2 diabetes or dyslipidaemia monogenic
  • Endocrine disorders
  • Smoking
  • Lipid lowering medications or hypertension medications
  • Food allergies and aversions to any food in the composition of experimental menus
  • Subjects with special dietary habits (e.g. vegetarianism)
  • Subject with a calculated Framingham risk of cardiovascular disease (CVD) > 20%

Sites / Locations

  • Richardson Centre for Functional Foods and Nutraceuticals
  • Institute of Nutrition and Funtional Foods

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cheese diet

Butter diet

CHO diet

MUFA diet

PUFA diet

Arm Description

A 4-week experimental diet with all meals and foods be provided to participants, including 90g of regular cheddar cheese daily per 2500 kcal. The diet will contain 13% of saturated fat (SFA), 14% of mono-unsaturated fat (MUFA), 5% of polyunsaturated fat (PUFA) and 53% of carbohydrate (CHO).

A 4-week experimental diet with all meals and foods be provided to participants, the diet will contain 13% of SFA mostly from butter. The diet will contain 14% of MUFA, 5% of PUFA and 53% of CHO.

A 4-week experimental diet with all meals and foods will provided to participants. The diet will contain 60% of CHO, 6% of SFA, 14% of MUFA and 5% of PUFA.

A 4-week experimental diet with all meals and foods be provided to participants. The diet will contain 21% of MUFA, 6% of SFA, 5% of PUFA and 53% of CHO.

A 4-week experimental diet with all meals and foods will be provided to participants. The diet will contain 12% of PUFA, 14% of MUFA, 6% of SFA and 53% of CHO.

Outcomes

Primary Outcome Measures

Change in High-Density-Lipoproteins concentrations (HDL-C)
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA

Secondary Outcome Measures

Change in HDL-C particle size and subclass
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Change in HDL cholesterol efflux
In a subset of individual; Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Change in Low Density Lipoproteins (LDL) particle size
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Change in C-Reactive Proteins (CRP) concentrations
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Change in adiponectin concentrations
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA

Full Information

First Posted
April 1, 2014
Last Updated
February 21, 2018
Sponsor
Laval University
Collaborators
Agriculture and Agri-Food Canada, Dairy Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02106208
Brief Title
Study of the Impact of Dairy Fat on Cardiovascular Health.
Acronym
HDL
Official Title
Study of the Impact of Dairy Fat on Cardiovascular Health.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Agriculture and Agri-Food Canada, Dairy Farmers of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese consumption, with potentially important impact on this key industry in Canada. This is in part due to the commonly accepted notion that saturated fat in the diet, of which cheese contributes significantly, increases the risk of heart disease. Yet, a rather large body of recent evidence suggests that saturated fat may have been unfairly demonized and that its impact on the risk of heart disease may in fact be less important than originally thought. This concept that dairy fat increases the risk of heart attacks therefore needs to be revisited, and this is one of the key objectives of this proposed research program. The proposed research is designed to investigate for the first time if dairy fat improves the levels of the so-called "good cholesterol", a protective risk factor that has been essentially ignored in the arguments supporting the reduction of saturated fat for heart health. Our hypothesis is that consumption of SFA from dairy (cheese) compared with a low fat diet and diets rich in MUFA and PUFA leads to favorable changes in plasma HDL-C concentrations and functional characteristics. Consumption of SFA from dairy (cheese) also increases LDL particle size, reduces inflammation and has no deleterious impact on plasma LDL-C and apolipoproteins B (apoB) concentrations compared with a low fat diet.
Detailed Description
This is a multi-center randomized crossover controlled feeding study. Briefly, adult men and women will be recruited in the Quebec City and Winnipeg metropolitan area through the media (newspaper, radio), local lipid clinics and mailing lists (n=90). Participants will be randomized to a series of 5 experimental diets of 4 weeks each: 1- Cheese diet, 2- Butter diet, 3- Carbohydrate (CHO) diet, 4- MUFA diet, 5- PUFA diet. Usual energy intake will be estimated at the beginning of the study using validated tools. Experimental diets will be provided as part of a full feeding protocol under carefully controlled isocaloric conditions to maintain body weight constant. All meals and foods will be provided to participants so that control for energy and macronutrient intake will be optimized. The breakfast meal will represent approximately 30% of the daily energy intake whereas the lunch and dinner meals each will provide 35% of daily energy intake. Participants will be instructed to consume their entire meals. A seven-day cyclic menu will be used. The diets will be separated by washout periods of 4 weeks. Blood samples will be collected on two consecutive days before and after each dietary phase. The mean of the two consecutive measurements will be used in the analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cheese diet
Arm Type
Experimental
Arm Description
A 4-week experimental diet with all meals and foods be provided to participants, including 90g of regular cheddar cheese daily per 2500 kcal. The diet will contain 13% of saturated fat (SFA), 14% of mono-unsaturated fat (MUFA), 5% of polyunsaturated fat (PUFA) and 53% of carbohydrate (CHO).
Arm Title
Butter diet
Arm Type
Experimental
Arm Description
A 4-week experimental diet with all meals and foods be provided to participants, the diet will contain 13% of SFA mostly from butter. The diet will contain 14% of MUFA, 5% of PUFA and 53% of CHO.
Arm Title
CHO diet
Arm Type
Experimental
Arm Description
A 4-week experimental diet with all meals and foods will provided to participants. The diet will contain 60% of CHO, 6% of SFA, 14% of MUFA and 5% of PUFA.
Arm Title
MUFA diet
Arm Type
Experimental
Arm Description
A 4-week experimental diet with all meals and foods be provided to participants. The diet will contain 21% of MUFA, 6% of SFA, 5% of PUFA and 53% of CHO.
Arm Title
PUFA diet
Arm Type
Experimental
Arm Description
A 4-week experimental diet with all meals and foods will be provided to participants. The diet will contain 12% of PUFA, 14% of MUFA, 6% of SFA and 53% of CHO.
Intervention Type
Other
Intervention Name(s)
Cheese diet
Intervention Type
Other
Intervention Name(s)
Butter diet
Intervention Type
Other
Intervention Name(s)
CHO diet
Intervention Type
Other
Intervention Name(s)
MUFA diet
Intervention Type
Other
Intervention Name(s)
PUFA diet
Primary Outcome Measure Information:
Title
Change in High-Density-Lipoproteins concentrations (HDL-C)
Description
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Time Frame
4 weeks (end-point value)
Secondary Outcome Measure Information:
Title
Change in HDL-C particle size and subclass
Description
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Time Frame
4 weeks (end-point value)
Title
Change in HDL cholesterol efflux
Description
In a subset of individual; Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Time Frame
4 weeks (end-point value)
Title
Change in Low Density Lipoproteins (LDL) particle size
Description
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Time Frame
4 weeks (end-point value)
Title
Change in C-Reactive Proteins (CRP) concentrations
Description
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Time Frame
4 weeks (end-point value)
Title
Change in adiponectin concentrations
Description
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are Cheese vs Butter, Cheese vs CHO, MUFA, PUFA Butter vs. CHO, MUFA, PUFA
Time Frame
4 weeks (end-point value)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women age between 18 and 65 years Waist circumference >80.0 cm for women and >94.0 cm for men Plasma concentration of triglycerides >1.70 mmol / L Stable weight for 6 months before the start of the study (+/- 5lbs) Exclusion Criteria: Men or women aged under 18 years or over 65 years History of CVD, type 2 diabetes or dyslipidaemia monogenic Endocrine disorders Smoking Lipid lowering medications or hypertension medications Food allergies and aversions to any food in the composition of experimental menus Subjects with special dietary habits (e.g. vegetarianism) Subject with a calculated Framingham risk of cardiovascular disease (CVD) > 20%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît Lamarche, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richardson Centre for Functional Foods and Nutraceuticals
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 6C5
Country
Canada
Facility Name
Institute of Nutrition and Funtional Foods
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29659963
Citation
Brassard D, Arsenault BJ, Boyer M, Bernic D, Tessier-Grenier M, Talbot D, Tremblay A, Levy E, Asztalos B, Jones PJH, Couture P, Lamarche B. Saturated Fats from Butter but Not from Cheese Increase HDL-Mediated Cholesterol Efflux Capacity from J774 Macrophages in Men and Women with Abdominal Obesity. J Nutr. 2018 Apr 1;148(4):573-580. doi: 10.1093/jn/nxy014.
Results Reference
derived
PubMed Identifier
28251937
Citation
Brassard D, Tessier-Grenier M, Allaire J, Rajendiran E, She Y, Ramprasath V, Gigleux I, Talbot D, Levy E, Tremblay A, Jones PJ, Couture P, Lamarche B. Comparison of the impact of SFAs from cheese and butter on cardiometabolic risk factors: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):800-809. doi: 10.3945/ajcn.116.150300. Epub 2017 Mar 1.
Results Reference
derived

Learn more about this trial

Study of the Impact of Dairy Fat on Cardiovascular Health.

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