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

Healthy Clinical Trial

— FROMAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623790
• Other study ID #: Fromage-INAF
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: August 23, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Canada	Institute of Nutrition and Functional Foods (INAF)	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).