Clinical Trials Directory

Trials / Completed

CompletedNCT02763930

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

Study of the Impact of Low Fat Dairy (Milk) and High Fat Dairy (Cheese) Consumption on Daytime Ambulatory Blood Pressure and Other Cardiometabolic Risk Factors

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Laval University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERControl diet
OTHERMilk diet
OTHERGABA-rich cheese diet

Timeline

Start date
2016-02-01
Primary completion
2017-07-01
Completion
2017-12-01
First posted
2016-05-05
Last updated
2018-02-22

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02763930. Inclusion in this directory is not an endorsement.