Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
FROMAGE
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedAugust 24, 2017
August 1, 2017
5 months
December 2, 2015
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)
EXPERIMENTALSubjects 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).
Test meal (cheddar cheese)
EXPERIMENTALSubjects 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).
Test meal (cream cheese)
EXPERIMENTALSubjects 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).
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).
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).
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).
Eligibility Criteria
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
- Laval Universitylead
Study Sites (1)
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6, Canada
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.
PMID: 28978543DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Couture, MD, PhD, FRCP
Laval University
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