HealthyFROMAGENCT02623790
Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
A study testing Test meal (butter), Test meal (cheddar cheese) and Test meal (cream cheese) in people with Healthy, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test meal (butter), Test meal (cheddar cheese) and Test meal (cream cheese)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-65 years (men and women)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6
About this study
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.
- Conditions
- Healthy
- Being tested
- Test meal (butter), Test meal (cheddar cheese), Test meal (cream cheese)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal (butter)Other
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)Other
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)Other
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 group | Role | What they receive |
|---|---|---|
| Test meal (butter) | Experimental | 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). Receives: Other: Test meal (butter) |
| Test meal (cheddar cheese) | Experimental | 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). Receives: Other: Test meal (cheddar cheese) |
| Test meal (cream cheese) | Experimental | 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). Receives: Other: Test meal (cream cheese) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in triglyceride concentrations 4h following the test meals ingestion
Measured: 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
Measured: 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
Measured: 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
Measured: At week 0, week 2 and week 4 (at the end of the three test meals).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD, PhD, FRCP, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623790
- Sponsor's protocol ID
- Fromage-INAF
- Acronym
- FROMAGE
- Status last verified
- Aug 2017
- First submitted
- 2 Dec 2015
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28978543
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
- ClinicalTrials.gov ID
- NCT02623790
- Acronym / sponsor ID
- FROMAGE / Fromage-INAF
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test meal (butter) | Experimental | Other: 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). |
| Test meal (cheddar cheese) | Experimental | Other: 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). |
| Test meal (cream cheese) | Experimental | Other: 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18-65 years (men and women)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 (butter) |
| 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 (cheddar cheese) |
| 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). | Other | Test meal (cream cheese) |
Primary outcome
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).
3 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Derived from this study: PubMed 28978543Drouin-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Couture, MD, PhD, FRCP principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal (butter), Test meal (cheddar cheese) and Test meal (cream cheese) in people with Healthy, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.