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

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ClinicalTrials.gov Identifier: NCT02623790
Recruitment Status : Completed
First Posted : December 8, 2015
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Patrick Couture, Laval University

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.


Condition or disease Intervention/treatment Phase
Healthy Other: Test meal (butter) Other: Test meal (cheddar cheese) Other: Test meal (cream cheese) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

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).




Primary Outcome Measures :
  1. 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 Measures :
  1. 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). ]
  2. 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). ]
  3. 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). ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623790


Locations
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Canada
Institute of Nutrition and Functional Foods (INAF)
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Patrick Couture, MD, PhD, FRCP Laval University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patrick Couture, MD, PhD, FRCP, Laval University
ClinicalTrials.gov Identifier: NCT02623790     History of Changes
Other Study ID Numbers: Fromage-INAF
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases