Study of the Impact of Dairy Fat on Cardiovascular Health.

NCT02106208 | Completed

• 1 other identifier: INAF-2013-251
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in High-Density-Lipoproteins concentrations (HDL-C)

  Post-diet values will be compared; the primary analysis (pre-determined comparisons) are 1. Cheese vs Butter, 2. Cheese vs CHO, MUFA, PUFA 3. Butter vs. CHO, MUFA, PUFA

  4 weeks (end-point value)

Secondary Outcomes (5)

• Change in HDL-C particle size and subclass

  4 weeks (end-point value)

• Change in HDL cholesterol efflux

  4 weeks (end-point value)

• Change in Low Density Lipoproteins (LDL) particle size

  4 weeks (end-point value)

• Change in C-Reactive Proteins (CRP) concentrations

  4 weeks (end-point value)

• Change in adiponectin concentrations

  4 weeks (end-point value)

Study Arms (5)

Cheese diet

EXPERIMENTAL

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).

Other: Cheese diet

Butter diet

EXPERIMENTAL

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.

Other: Butter diet

CHO diet

EXPERIMENTAL

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.

Other: CHO diet

MUFA diet

EXPERIMENTAL

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.

Other: MUFA diet

PUFA diet

EXPERIMENTAL

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.

Other: PUFA diet

Interventions

Cheese diet OTHER

Cheese diet

Butter diet OTHER

Butter diet

CHO diet OTHER

CHO diet

MUFA diet OTHER

MUFA diet

PUFA diet OTHER

PUFA diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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%

Sponsors & Collaborators

• Laval University: lead
• Agriculture and Agri-Food Canada: collaborator
• Dairy Farmers of Canada: collaborator

Study Sites (2)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Institute of Nutrition and Funtional Foods

Québec, G1V 0A6, Canada

Location

Related Publications (2)

• 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.

  PMID: 29659963 DERIVED

• 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.

  PMID: 28251937 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Benoît Lamarche, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

CA (2)