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Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study (FROMAGE)

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Test meal (butter)
Test meal (cheddar cheese)
Test meal (cream cheese)
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Institute of Nutrition and Functional Foods (INAF)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Test meal (butter)

Test meal (cheddar cheese)

Test meal (cream cheese)

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Change in triglyceride concentrations 4h following the test meals ingestion

Secondary Outcome Measures

Change in triglyceride concentrations (area under the curve) following the test meals ingestion
Change in free fatty acids concentrations (area under the curve) following the test meals ingestion
Change in apolipoprotein B48 concentrations (area under the curve) following the test meals ingestion

Full Information

First Posted
December 2, 2015
Last Updated
August 23, 2017
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02623790
Brief Title
Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
Acronym
FROMAGE
Official Title
Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test meal (butter)
Arm Type
Experimental
Arm Description
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).
Arm Title
Test meal (cheddar cheese)
Arm Type
Experimental
Arm Description
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).
Arm Title
Test meal (cream cheese)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Test meal (butter)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Test meal (cheddar cheese)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Test meal (cream cheese)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in triglyceride concentrations 4h following the test meals ingestion
Time Frame
At week 0, week 2 and week 4 (at the end of the three test meals).
Secondary Outcome Measure Information:
Title
Change in triglyceride concentrations (area under the curve) following the test meals ingestion
Time Frame
At week 0, week 2 and week 4 (at the end of the three test meals).
Title
Change in free fatty acids concentrations (area under the curve) following the test meals ingestion
Time Frame
At week 0, week 2 and week 4 (at the end of the three test meals).
Title
Change in apolipoprotein B48 concentrations (area under the curve) following the test meals ingestion
Time Frame
At week 0, week 2 and week 4 (at the end of the three test meals).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18-65 years (men and women) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Couture, MD, PhD, FRCP
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nutrition and Functional Foods (INAF)
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28978543
Citation
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.
Results Reference
derived

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Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study

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