Metabolic SyndromeHDLNCT02106208
Study of the Impact of Dairy Fat on Cardiovascular Health.
A study testing Cheese diet, Butter diet and CHO diet in people with Metabolic Syndrome, run by Laval University at 2 sites in Canada.
Trial summary
Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese consumption, with potentially important impact on this key industry in Canada. This is in part due to the commonly accepted notion that saturated fat in the diet, of which cheese contributes significantly, increases the risk of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Cheese diet, Butter diet and CHO diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2014to Dec 2017
- 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
- Men and women age between 18 and 65 years
- Waist circumference >80.0 cm for women and >94.0 cm for men
- Plasma concentration of triglycerides >1.70 mmol / L
- Stable weight for 6 months before the start of the study (+/- 5lbs)
Who cannot join
- Men or women aged under 18 years or over 65 years
- History of CVD, type 2 diabetes or dyslipidaemia monogenic
- Endocrine disorders
- Smoking
- Lipid lowering medications or hypertension medications
- Food allergies and aversions to any food in the composition of experimental menus
- Subjects with special dietary habits (e.g. vegetarianism)
- Subject with a calculated Framingham risk of cardiovascular disease (CVD) > 20%
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institute of Nutrition and Funtional Foods
Québec, G1V 0A6
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 6C5
About this study
Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese consumption, with potentially important impact on this key industry in Canada. This is in part due to the commonly accepted notion that saturated fat in the diet, of which cheese contributes significantly, increases the risk of heart disease. Yet, a rather large body of recent evidence suggests that saturated fat may have been unfairly demonized and that its impact on the risk of heart disease may in fact be less important than originally thought. This concept that dairy fat increases the risk of heart attacks therefore needs to be revisited, and this is one of the key objectives of this proposed research program.
The proposed research is designed to investigate for the first time if dairy fat improves the levels of the so-called "good cholesterol", a protective risk factor that has been essentially ignored in the arguments supporting the reduction of saturated fat for heart health.
Our hypothesis is that consumption of SFA from dairy (cheese) compared with a low fat diet and diets rich in MUFA and PUFA leads to favorable changes in plasma HDL-C concentrations and functional characteristics. Consumption of SFA from dairy (cheese) also increases LDL particle size, reduces inflammation and has no deleterious impact on plasma LDL-C and apolipoproteins B (apoB) concentrations compared with a low fat diet.
Read the detailed description
This is a multi-center randomized crossover controlled feeding study. Briefly, adult men and women will be recruited in the Quebec City and Winnipeg metropolitan area through the media (newspaper, radio), local lipid clinics and mailing lists (n=90).
Participants will be randomized to a series of 5 experimental diets of 4 weeks each: 1- Cheese diet, 2- Butter diet, 3- Carbohydrate (CHO) diet, 4- MUFA diet, 5- PUFA diet. Usual energy intake will be estimated at the beginning of the study using validated tools. Experimental diets will be provided as part of a full feeding protocol under carefully controlled isocaloric conditions to maintain body weight constant. All meals and foods will be provided to participants so that control for energy and macronutrient intake will be optimized. The breakfast meal will represent approximately 30% of the daily energy intake whereas the lunch and dinner meals each will provide 35% of daily energy intake. Participants will be instructed to consume their entire meals. A seven-day cyclic menu will be used. The diets will be separated by washout periods of 4 weeks. Blood samples will be collected on two consecutive days before and after each dietary phase. The mean of the two consecutive measurements will be used in the analyses.
- Conditions
- Metabolic Syndrome
- Being tested
- Cheese diet, Butter diet, CHO diet, MUFA diet, PUFA diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheese dietOther
Butter dietOther
CHO dietOther
MUFA dietOther
PUFA dietOther
| Study group | Role | What they receive |
|---|---|---|
| Cheese diet | Experimental | A 4-week experimental diet with all meals and foods be provided to participants, including 90g of regular cheddar cheese daily per 2500 kcal. The diet will contain 13% of saturated fat (SFA), 14% of mono-unsaturated fat (MUFA), 5% of polyunsaturated fat (PUFA) and 53% of carbohydrate (CHO). Receives: Other: Cheese diet |
| Butter diet | Experimental | A 4-week experimental diet with all meals and foods be provided to participants, the diet will contain 13% of SFA mostly from butter. The diet will contain 14% of MUFA, 5% of PUFA and 53% of CHO. Receives: Other: Butter diet |
| CHO diet | Experimental | A 4-week experimental diet with all meals and foods will provided to participants. The diet will contain 60% of CHO, 6% of SFA, 14% of MUFA and 5% of PUFA. Receives: Other: CHO diet |
| MUFA diet | Experimental | A 4-week experimental diet with all meals and foods be provided to participants. The diet will contain 21% of MUFA, 6% of SFA, 5% of PUFA and 53% of CHO. Receives: Other: MUFA diet |
| PUFA diet | Experimental | A 4-week experimental diet with all meals and foods will be provided to participants. The diet will contain 12% of PUFA, 14% of MUFA, 6% of SFA and 53% of CHO. Receives: Other: PUFA diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in High-Density-Lipoproteins concentrations (HDL-C)
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are
- Cheese vs Butter,
- Cheese vs CHO, MUFA, PUFA
- Butter vs. CHO, MUFA, PUFA
Measured: 4 weeks (end-point value)
Secondary outcomes (5)
Change in HDL-C particle size and subclass
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are
- Cheese vs Butter,
- Cheese vs CHO, MUFA, PUFA
- Butter vs. CHO, MUFA, PUFA
Measured: 4 weeks (end-point value)
Change in HDL cholesterol efflux
In a subset of individual;
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are
- Cheese vs Butter,
- Cheese vs CHO, MUFA, PUFA
- Butter vs. CHO, MUFA, PUFA
Measured: 4 weeks (end-point value)
Change in Low Density Lipoproteins (LDL) particle size
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are
- Cheese vs Butter,
- Cheese vs CHO, MUFA, PUFA
- Butter vs. CHO, MUFA, PUFA
Measured: 4 weeks (end-point value)
Change in C-Reactive Proteins (CRP) concentrations
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are
- Cheese vs Butter,
- Cheese vs CHO, MUFA, PUFA
- Butter vs. CHO, MUFA, PUFA
Measured: 4 weeks (end-point value)
Change in adiponectin concentrations
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are
- Cheese vs Butter,
- Cheese vs CHO, MUFA, PUFA
- Butter vs. CHO, MUFA, PUFA
Measured: 4 weeks (end-point value)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Dairy Farmers of Canada
- Responsible party
- Principal investigator, Benoit Lamarche, Laval University
- Investigators
- Benoît Lamarche, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106208
- Sponsor's protocol ID
- INAF-2013-251
- Acronym
- HDL
- Status last verified
- Feb 2018
- First submitted
- 1 Apr 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brassard D, Arsenault BJ, Boyer M, Bernic D, Tessier-Grenier M, Talbot D, Tremblay A, Levy E, Asztalos B, Jones PJH, Couture P, Lamarche B. Saturated Fats from Butter but Not from Cheese Increase HDL-Mediated Cholesterol Efflux Capacity from J774 Macrophages in Men and Women with Abdominal Obesity. J Nutr. 2018 Apr 1;148(4):573-580. doi: 10.1093/jn/nxy014.
PubMed 29659963Brassard D, Tessier-Grenier M, Allaire J, Rajendiran E, She Y, Ramprasath V, Gigleux I, Talbot D, Levy E, Tremblay A, Jones PJ, Couture P, Lamarche B. Comparison of the impact of SFAs from cheese and butter on cardiometabolic risk factors: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):800-809. doi: 10.3945/ajcn.116.150300. Epub 2017 Mar 1.
PubMed 28251937
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Dairy Fat on Cardiovascular Health.
- ClinicalTrials.gov ID
- NCT02106208
- Acronym / sponsor ID
- HDL / INAF-2013-251
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Dairy Farmers of Canada
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Apr 2014 (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.
Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese consumption, with potentially important impact on this key industry in Canada. This is in part due to the commonly accepted notion that saturated fat in the diet, of which cheese contributes significantly, increases the risk of heart disease. Yet, a rather large body of recent evidence suggests that saturated fat may have been unfairly demonized and that its impact on the risk of heart disease may in fact be less important than originally thought. This concept that dairy fat increases the risk of heart attacks therefore needs to be revisited, and this is one of the key objectives of this proposed research program.
The proposed research is designed to investigate for the first time if dairy fat improves the levels of the so-called "good cholesterol", a protective risk factor that has been essentially ignored in the arguments supporting the reduction of saturated fat for heart health.
Our hypothesis is that consumption of SFA from dairy (cheese) compared with a low fat diet and diets rich in MUFA and PUFA leads to favorable changes in plasma HDL-C concentrations and functional characteristics. Consumption of SFA from dairy (cheese) also increases LDL particle size, reduces inflammation and has no deleterious impact on plasma LDL-C and apolipoproteins B (apoB) concentrations compared with a low fat diet.
Detailed description
This is a multi-center randomized crossover controlled feeding study. Briefly, adult men and women will be recruited in the Quebec City and Winnipeg metropolitan area through the media (newspaper, radio), local lipid clinics and mailing lists (n=90).
Participants will be randomized to a series of 5 experimental diets of 4 weeks each: 1- Cheese diet, 2- Butter diet, 3- Carbohydrate (CHO) diet, 4- MUFA diet, 5- PUFA diet. Usual energy intake will be estimated at the beginning of the study using validated tools. Experimental diets will be provided as part of a full feeding protocol under carefully controlled isocaloric conditions to maintain body weight constant. All meals and foods will be provided to participants so that control for energy and macronutrient intake will be optimized. The breakfast meal will represent approximately 30% of the daily energy intake whereas the lunch and dinner meals each will provide 35% of daily energy intake. Participants will be instructed to consume their entire meals. A seven-day cyclic menu will be used. The diets will be separated by washout periods of 4 weeks. Blood samples will be collected on two consecutive days before and after each dietary phase. The mean of the two consecutive measurements will be used in the analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cheese diet | Experimental | Other: Cheese dietA 4-week experimental diet with all meals and foods be provided to participants, including 90g of regular cheddar cheese daily per 2500 kcal. The diet will contain 13% of saturated fat (SFA), 14% of mono-unsaturated fat (MUFA), 5% of polyunsaturated fat (PUFA) and 53% of carbohydrate (CHO). |
| Butter diet | Experimental | Other: Butter dietA 4-week experimental diet with all meals and foods be provided to participants, the diet will contain 13% of SFA mostly from butter. The diet will contain 14% of MUFA, 5% of PUFA and 53% of CHO. |
| CHO diet | Experimental | Other: CHO dietA 4-week experimental diet with all meals and foods will provided to participants. The diet will contain 60% of CHO, 6% of SFA, 14% of MUFA and 5% of PUFA. |
| MUFA diet | Experimental | Other: MUFA dietA 4-week experimental diet with all meals and foods be provided to participants. The diet will contain 21% of MUFA, 6% of SFA, 5% of PUFA and 53% of CHO. |
| PUFA diet | Experimental | Other: PUFA dietA 4-week experimental diet with all meals and foods will be provided to participants. The diet will contain 12% of PUFA, 14% of MUFA, 6% of SFA and 53% of CHO. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women age between 18 and 65 years
- Waist circumference >80.0 cm for women and >94.0 cm for men
- Plasma concentration of triglycerides >1.70 mmol / L
- Stable weight for 6 months before the start of the study (+/- 5lbs)
Key exclusion criteria (8 listed)
- Men or women aged under 18 years or over 65 years
- History of CVD, type 2 diabetes or dyslipidaemia monogenic
- Endocrine disorders
- Smoking
- Lipid lowering medications or hypertension medications
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 |
|---|---|---|
| Cheese diet | Other | Cheese diet |
| Butter diet | Other | Butter diet |
| CHO diet | Other | CHO diet |
| MUFA diet | Other | MUFA diet |
| PUFA diet | Other | PUFA diet |
Primary outcome
Change in High-Density-Lipoproteins concentrations (HDL-C)
Time frame: 4 weeks (end-point value)
Post-diet values will be compared; the primary analysis (pre-determined comparisons) are 1. Cheese vs Butter, 2. Cheese vs CHO, MUFA, PUFA 3. Butter vs. CHO, MUFA, PUFA
5 secondary outcomes
Change in HDL-C particle size and subclass
Time frame: 4 weeks (end-point value)
Change in HDL cholesterol efflux
Time frame: 4 weeks (end-point value)
Change in Low Density Lipoproteins (LDL) particle size
Time frame: 4 weeks (end-point value)
Change in C-Reactive Proteins (CRP) concentrations
Time frame: 4 weeks (end-point value)
Change in adiponectin concentrations
Time frame: 4 weeks (end-point value)
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 22 Feb 2018.
- Derived from this study: PubMed 29659963Brassard D, Arsenault BJ, Boyer M, Bernic D, Tessier-Grenier M, Talbot D, Tremblay A, Levy E, Asztalos B, Jones PJH, Couture P, Lamarche B. Saturated Fats from Butter but Not from Cheese Increase HDL-Mediated Cholesterol Efflux Capacity from J774 Macrophages in Men and Women with Abdominal Obesity. J Nutr. 2018 Apr 1;148(4):573-580. doi: 10.1093/jn/nxy014.
- Derived from this study: PubMed 28251937Brassard D, Tessier-Grenier M, Allaire J, Rajendiran E, She Y, Ramprasath V, Gigleux I, Talbot D, Levy E, Tremblay A, Jones PJ, Couture P, Lamarche B. Comparison of the impact of SFAs from cheese and butter on cardiometabolic risk factors: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):800-809. doi: 10.3945/ajcn.116.150300. Epub 2017 Mar 1.
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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.
Benoît Lamarche, PhD principal investigator
Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cheese diet, Butter diet and CHO diet in people with Metabolic Syndrome, run by Laval University at 2 sites 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 4 inclusion and 8 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 High-Density-Lipoproteins concentrations (HDL-C) (time frame: 4 weeks (end-point value)). 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 NCT02106208, which also lists 2 linked publications.
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 22 Feb 2018.