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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

Tracking Information
First Submitted Date  ICMJE December 2, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date August 24, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
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). ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02623790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • 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). ]
  • 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). ]
  • 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). ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • 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). ]
  • Changee 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). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
Official Title  ICMJE Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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).
  • 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).
  • 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).
Study Arms  ICMJE
  • 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).
    Intervention: Other: Test meal (butter)
  • 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).
    Intervention: Other: Test meal (cheddar cheese)
  • 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).
    Intervention: Other: Test meal (cream cheese)
Publications * Drouin-Chartier JP, Tremblay AJ, Maltais-Giguère 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02623790
Other Study ID Numbers  ICMJE Fromage-INAF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Patrick Couture, Laval University
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Couture, MD, PhD, FRCP Laval University
PRS Account Laval University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP