Study of the Impact of Low Fat Dairy and High Fat Dairy Consumption on Daytime Ambulatory Blood Pressure (GABA2)

L

Laval University

Status

Completed

Conditions

Hypertension

Treatments

Other: Control diet
Other: GABA-rich cheese diet
Other: Milk diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02763930
INAF-2015-268

Details and patient eligibility

About

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.

Full description

This is a single-center randomized crossover controlled feeding study. Briefly, adult men and women will be recruited based primarily on blood pressure criteria in the Quebec City metropolitan area through the media (newspaper, radio) and mailing lists (n=60). Participants will be randomized to 3 experimental diets of 6 weeks each: 1- CONTROL dairy-free diet, 2- low fat dairy (MILK, 1% fat, 3 servings/d), 3- high-fat dairy (GABA-rich cheddar cheese, approximately 32% fat, 1 serving (50g)/d). 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. We have opted to test the impact of dairy intake over a 6-week period (as opposed to 4 or 5 weeks) to maximize the chance to observe clinically meaningful changes in blood pressure. Diets will be separated by a 4 to 8 week washout period. Randomization will be stratified by sex. Blood samples will be collected the day before each dietary phase and on 2 consecutive days after each dietary phase. The mean of the 2 consecutive measurements will be used in the analyses.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

60 participants in 3 patient groups

CONTROL (dairy-free)
Experimental group
Description:
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.
Treatment:
Other: Control diet
MILK (low fat dairy)
Experimental group
Description:
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.
Treatment:
Other: Milk diet
GABA-rich cheese (high-fat dairy )
Experimental group
Description:
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.
Treatment:
Other: GABA-rich cheese diet

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems