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

August 23, 2017 updated by: Patrick Couture, Laval University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 0A6
        • Institute of Nutrition and Functional Foods (INAF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test meal (butter)
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)
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).
Experimental: Test meal (cheddar cheese)
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)
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).
Experimental: Test meal (cream cheese)
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)
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
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
Time Frame: At week 0, week 2 and week 4 (at the end of the three test meals).
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
Time Frame: At week 0, week 2 and week 4 (at the end of the three test meals).
At week 0, week 2 and week 4 (at the end of the three test meals).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Patrick Couture, MD, PhD, FRCP, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fromage-INAF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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