NCT02623790

Brief Summary

Dairy products consumption is widely recommended in a healthy diet not only for bone growth and maintenance, but also as a protein, calcium and magnesium sources for an adequate diet. However, dairy products are a major dietary source of saturated fat that is associated with increased risk of coronary heart disease. ln this context, dietary guidelines still advocate a restriction in dietary saturated fat for optimal heart health. Nevertheless, the association between saturated fat and the risk of heart disease remains highly controversial within the scientific community. There is also emerging evidence that the impact of dietary saturated fat will be significantly influenced by the food matrix through which it is provided. Recent studies indicate that cheese could have a major influence on intestinal fat absorption and the magnitude of the after meal release of fat in blood circulation. This is of interest because substantial evidence exists indicating that elevated levels of the after meal fat levels are associated with increased cardiovascular risk. Therefore, the improvement of the after meal fat levels produced by cheese consumption could well be part of novel therapeutic approaches contributing to improve cardiovascular risk. The general objective of the proposed research is to investigate how cheese consumption affects the after meal release of fat in blood circulation in healthy subjects. Our hypothesis is that, compared to butter, cheese consumption will have a beneficial impact on the after meal fat levels in healthy subjects. Favourable results from the proposed study will provide novel and much warranted evidence on the importance of considering changes in the after meal fat levels, not only bad cholesterol, as part of the on-going saturated fat-heart disease debate and that cheese should indeed be part of a healthy diet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

December 2, 2015

Last Update Submit

August 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in triglyceride concentrations 4h following the test meals ingestion

    At week 0, week 2 and week 4 (at the end of the three test meals).

Secondary Outcomes (3)

  • Change in triglyceride concentrations (area under the curve) following the test meals ingestion

    At week 0, week 2 and week 4 (at the end of the three test meals).

  • Change in free fatty acids concentrations (area under the curve) following the test meals ingestion

    At week 0, week 2 and week 4 (at the end of the three test meals).

  • Change in apolipoprotein B48 concentrations (area under the curve) following the test meals ingestion

    At week 0, week 2 and week 4 (at the end of the three test meals).

Study Arms (3)

Test meal (butter)

EXPERIMENTAL

Subjects will eat one test meal containing 33g of lipids from butter (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).

Other: Test meal (butter)

Test meal (cheddar cheese)

EXPERIMENTAL

Subjects will eat one test meal containing 33g of lipids from cheddar cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).

Other: Test meal (cheddar cheese)

Test meal (cream cheese)

EXPERIMENTAL

Subjects will eat one test meal containing 33g of lipids from cream cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).

Other: Test meal (cream cheese)

Interventions

Subjects will eat one meal test containing 33g of lipids from butter (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).

Test meal (butter)

Subjects will eat one meal test containing 33g of lipids from cheddar cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).

Test meal (cheddar cheese)

Subjects will eat one meal test containing 33g of lipids from cream cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).

Test meal (cream cheese)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65 years (men and women)

You may not qualify if:

  • Smokers (more than 1 cigarette/d)
  • Body weight variation more than 10% during the last 6 months prior to the study baseline
  • BMI more than 35 kg/m2
  • Previous history of cardiovascular disease
  • Subjects with type 2 diabetes
  • Subjects with monogenic dyslipidemia
  • Subjects taking anti-inflammatory drugs
  • Subjects with endocrine or gastrointestinal disease
  • Allergy/intolerance to dairy
  • Clinical use of vitamin D and calcium supplements
  • Vegetarians
  • Subjects who are in situation or have a condition that, in the opinion of the investigators, may interfere with optimal participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition and Functional Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • Drouin-Chartier JP, Tremblay AJ, Maltais-Giguere J, Charest A, Guinot L, Rioux LE, Labrie S, Britten M, Lamarche B, Turgeon SL, Couture P. Differential impact of the cheese matrix on the postprandial lipid response: a randomized, crossover, controlled trial. Am J Clin Nutr. 2017 Dec;106(6):1358-1365. doi: 10.3945/ajcn.117.165027. Epub 2017 Oct 4.

MeSH Terms

Interventions

Butter

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Patrick Couture, MD, PhD, FRCP

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FRCP

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 8, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

August 24, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations