Study of the Impact of Dairy Fat on Cardiovascular Health.

NCT ID: NCT02106208

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cheese diet

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).

Group Type: EXPERIMENTAL

Cheese diet

Intervention Type: OTHER

Butter diet

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.

Group Type: EXPERIMENTAL

Butter diet

Intervention Type: OTHER

CHO diet

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.

Group Type: EXPERIMENTAL

CHO diet

Intervention Type: OTHER

MUFA diet

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.

Group Type: EXPERIMENTAL

MUFA diet

Intervention Type: OTHER

PUFA diet

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.

Group Type: EXPERIMENTAL

PUFA diet

Intervention Type: OTHER

Interventions

Cheese diet

Intervention Type: OTHER

Butter diet

Intervention Type: OTHER

CHO diet

Intervention Type: OTHER

MUFA diet

Intervention Type: OTHER

PUFA diet

Intervention Type: OTHER

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role: collaborator

Dairy Farmers of Canada

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Benoit Lamarche

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benoît Lamarche, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Institute of Nutrition and Funtional Foods

Québec, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29659963 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28251937 (View on PubMed)

Other Identifiers

INAF-2013-251

Identifier Type: -

Identifier Source: org_study_id