Study of the Impact of Low Fat Dairy and High Fat Dairy Consumption on Daytime Ambulatory Blood Pressure

NCT02763930 | Completed

• 1 other identifier: INAF-2015-268
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. The proposed research is designed to investigate which risk factors for heart disease (e.g. cholesterol, blood pressure) are beneficially modified when low fat (milk) and high fat (cheese) dairy products are consumed. Our hypotheses are : (1) Consumption of low fat dairy (milk 1% fat) compared with a dairy-free control diet reduces daytime ambulatory systolic blood pressure and reduces inflammation; (2) Consumption of a high fat dairy (GABA-rich cheese) compared with a dairy-free control diet reduces daytime ambulatory systolic blood pressure and has favorable effects on LDL particle size, inflammation and HDL-C concentration.

Conditions

Hypertension

Keywords

Cardiovascular disease; Blood pressure; Hypertension; Dairy products; Milk; Cheese

Outcome Measures

Primary Outcomes (1)

• Variation in daytime ambulatory systolic blood pressure after dairy product consumption (Milk or GABA-rich cheese) compared with the control dairy-free diet.

  6 weeks (end-point value)

Secondary Outcomes (6)

• Variation in lipid concentrations (LDL-C, HDL-C, TG)

  6 weeks (end-point value)

• Variation in apolipoprotein B (ApoB) concentration

  6 weeks (end-point value)

• Variation in Low Density Lipoproteins (LDL) particle size

  6 weeks (end-point value)

• Variation in High Density Lipoproteins (HDL) particle size

  6 weeks (end-point value)

• Variation in C-Reactive Protein (CRP) concentration

  6 weeks (end-point value)

Study Arms (3)

CONTROL (dairy-free)

EXPERIMENTAL

6 weeks experimental diet with all meals and foods provided to participants. The diet contain 32% of fat, 11% of saturated fat (SFA), 13% of mono-unsaturated fat (MUFA), 8% of polyunsaturated fat (PUFA) and 15% of proteins.

Other: Control diet

MILK (low fat dairy)

EXPERIMENTAL

6 weeks experimental diet with all meals and foods provided to participants including 3 servings/day of milk (1% fat) per 2500 kcal. The diet contain 32% of fat, 11% of SFA, 13% of MUFA, 8% of PUFA and 15% of proteins.

Other: Milk diet

GABA-rich cheese (high-fat dairy )

EXPERIMENTAL

6 weeks experimental diet with all meals and foods provided to participants including 50g/day of GABA-rich cheddar cheese (approximately 32% fat). The diet contain 32% of fat, 13% of SFA, 13% of MUFA, 6% of PUFA and 15% of proteins.

Other: GABA-rich cheese diet

Interventions

Control diet OTHER

CONTROL (dairy-free)

Milk diet OTHER

MILK (low fat dairy)

GABA-rich cheese diet OTHER

GABA-rich cheese (high-fat dairy )

Eligibility Criteria

• Age: 18 Years - 75 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 75 years
• Average daytime systolic blood pressure ≥ 125 mmHg (blood pressure medication must be stopped 2 weeks before the start of the study).
• Stable weight for 3 months before the start of the study (+/- 5lbs)

You may not qualify if:

• Men or women aged under 18 years or over 75 years
• Average daytime systolic blood pressure ≥ 160 mmHg
• Average daytime diastolic blood pressure ≥ 110 mmHg
• History of cardiovascular disease, type 2 diabetes or dyslipidaemia monogenic
• Endocrine disorders
• Regular smoker
• Lipid lowering medications or diabetes medications
• Food allergies and aversions to any food in the composition of experimental menus
• Subjects with special dietary habits (e.g. vegetarianism)

Sponsors & Collaborators

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

Study Sites (1)

Institute of Nutrition and Fonctional Foods

Québec, G1V 0A6, Canada

Location

Related Publications (1)

• Rancourt-Bouchard M, Gigleux I, Guay V, Charest A, Saint-Gelais D, Vuillemard JC, Lamarche B, Couture P. Effects of regular-fat and low-fat dairy consumption on daytime ambulatory blood pressure and other cardiometabolic risk factors: a randomized controlled feeding trial. Am J Clin Nutr. 2020 Jan 1;111(1):42-51. doi: 10.1093/ajcn/nqz251.

  PMID: 31584063 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Benoit 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: Professor

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)