Cardiovascular DiseasePLINCT01444326
Impact of Dairy Consumption on Inflammation: a Clinical Study (PLI)
A study testing Dairy in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
Trial summary
Inflammation and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Dairy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Dec 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 70 years
- Presenting a subclinical inflammation (Plasma CRP >2 and <10 mg/l)
- Abdominal obesity, waist girth >94 cm in men and >80 cm in women
- Consumption of dairy products fewer than 2 servings per day
- Pre-menopausal women with regular menstrual cycle for the last 3 months
Who cannot join
- Plasma CRP <2 or >10 mg/l
- Smokers (>1 cigarette/day)
- Body weight variation >10% for the last 6 months prior to the study baseline
- BMI >35 kg/m2
- Previous history of CVD, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia, hypertension
Show all 12Show fewer
- Post menopausal women who have initiated hormone replacement therapy within 6 months of study onset
- Endocrine or gastrointestinal disorders
- Smoking
- Food allergies, milk aversion or intolerant to lactose
- Clinical use of vitamin D or calcium supplements
- Vegetarianism
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Québec, Quebec, G1V 0A6
About this study
Official title: Impact of Dairy Consumption on Inflammation: a Clinical Study
Inflammation and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). These pro-atherogenic states are strongly correlated and often found co-segregating among individuals with obesity and the metabolic syndrome. There is increasing evidence to support the use in clinical practice of these novel markers of atherosclerosis and CVD risk. Recent data from the JUPITER study (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) has provided undisputable evidence that treating patients with elevated plasma CRP concentrations, a marker of systemic subclinical inflammation, leads to marked reduction in the risk of CHD even in patients with highly desirable LDL-C levels. There is also accumulating evidence associating endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to an increased risk of CVD. While there are more and more studies on how diet affects inflammation and endothelial function, the impact of dairy consumption per se on these novel risk factors for CVD has not been well characterized.
The purpose of this study was to investigate the impact of dairy consumption on markers of inflammation and other risk factors in men and women with low grade systemic inflammation.
Read the detailed description
This research will be undertaken as a multicenter randomized cross-over controlled study. A total of 140 men and women with subclinical inflammation (plasma CRP 2-10 mg/l) but otherwise healthy will consume two diets, one rich in dairy and one without dairy, while consuming a diet low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (milk, yogurt, cheese) into their every day diet. During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products. Each diet will be undertaken consecutively in random order and will have duration of approximately 28 days each (4 weeks).The primary analysis consists in comparing inflammation markers and related risk factors between the two treatments. The study is designed to detect a 12-16% difference in plasma CRP concentrations (the primary endpoint) between the control and the dairy diet.
A 2-week stabilization run-in period will precede the randomization of participants. During this run-in period, participants will be asked and instructed to adapt their diet to a prudent dietary pattern low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). The total amount of fat in the diet will not be restricted, with recommendations ranging from 25-35% of energy. However, substitution of saturated for unsaturated fat will be advocated. Sodium intake <2300 mg/d will also be recommended. Recommendations will also include advice on how to restrict the consumption of processed and energy dense foods. The run-in diet will not include specific recommendation on dairy products. Participants will have the choice to include/exclude dairy from their prudent diet, as long as they comply with the main dietary recommendations. This 2-week run-in period will allow participants to familiarize themselves with the dietary recommendations used during the intervention per se. The two diets will be separated by a 4-week wash out period and will also consist to the prudent dietary pattern recommended. It must be stressed that foods will not be provided during the run-in and wash-out periods. These periods are imposed to minimize the inter- and intra-individual variability before and between the experimental phases.
- Conditions
- Cardiovascular Disease
- Being tested
- Dairy
- Keywords
- Keywords;, Cardiovascular disease, Dairy, Inflammation, Blood lipids
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DairyOther
Also called Dairy products, milk, cheese, yogourt
During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (375 ml of milk, 175 g of yogurt, 30 g of cheese) into their every day diet.
During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products (375 ml of fruit juice, 1 homemade cookie, 20 g of cashew).
| Study group | Role | What they receive |
|---|---|---|
| Dairy diet | Experimental | Not described Receives: Other: Dairy |
| Control diet | Placebo comparator | Not described Receives: Other: Dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma CRP concentrations
Measured: At the beginning of the study and the end of the two 4-week diets
Secondary outcomes (6)
Change in endothelial function
Measured: At the end of the two 4-week diets
Change in plasma lipid concentrations (LDL-Cholesterol, HDL-C, triglycerides)
Measured: At the beginning of the study and the end of the two 4-week diets
Change in insulin levels
Measured: At the beginning of the study and the end of the two 4-week diets
Change in anthropometric measures (waist and hip circumferences)
Measured: At the beginning of the study and the end of the two 4-week diets
Change in blood pressure
Measured: At the begining of the study and the end of the two 4-week diets
Change in CRP intravascular kinetics (in a subsample of the entire study population)
Measured: At the end of the two 4-week diets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionDec 2013
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 Cardiovascular DiseaseStudies 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
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT01444326
- Sponsor's protocol ID
- INAF-2010-155
- Acronym
- PLI
- Status last verified
- Apr 2014
- First submitted
- 28 Sep 2011
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdullah MM, Cyr A, Lepine MC, Eck PK, Couture P, Lamarche B, Jones PJ. Common Variants in Cholesterol Synthesis- and Transport-Related Genes Associate with Circulating Cholesterol Responses to Intakes of Conventional Dairy Products in Healthy Individuals. J Nutr. 2016 May;146(5):1008-16. doi: 10.3945/jn.115.222208. Epub 2016 Apr 6.
PubMed 27052530Labonte ME, Cyr A, Abdullah MM, Lepine MC, Vohl MC, Jones P, Couture P, Lamarche B. Dairy product consumption has no impact on biomarkers of inflammation among men and women with low-grade systemic inflammation. J Nutr. 2014 Nov;144(11):1760-7. doi: 10.3945/jn.114.200576. Epub 2014 Sep 3.
PubMed 25332474
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dairy Consumption on Inflammation: a Clinical Study
- ClinicalTrials.gov ID
- NCT01444326
- Acronym / sponsor ID
- PLI / INAF-2010-155
- Conditions
- Cardiovascular Disease
- Keywords
- Keywords;, Cardiovascular disease, Dairy, Inflammation, Blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Sep 2011 (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.
Inflammation and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). These pro-atherogenic states are strongly correlated and often found co-segregating among individuals with obesity and the metabolic syndrome. There is increasing evidence to support the use in clinical practice of these novel markers of atherosclerosis and CVD risk. Recent data from the JUPITER study (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) has provided undisputable evidence that treating patients with elevated plasma CRP concentrations, a marker of systemic subclinical inflammation, leads to marked reduction in the risk of CHD even in patients with highly desirable LDL-C levels. There is also accumulating evidence associating endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to an increased risk of CVD. While there are more and more studies on how diet affects inflammation and endothelial function, the impact of dairy consumption per se on these novel risk factors for CVD has not been well characterized.
The purpose of this study was to investigate the impact of dairy consumption on markers of inflammation and other risk factors in men and women with low grade systemic inflammation.
Detailed description
This research will be undertaken as a multicenter randomized cross-over controlled study. A total of 140 men and women with subclinical inflammation (plasma CRP 2-10 mg/l) but otherwise healthy will consume two diets, one rich in dairy and one without dairy, while consuming a diet low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (milk, yogurt, cheese) into their every day diet. During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products. Each diet will be undertaken consecutively in random order and will have duration of approximately 28 days each (4 weeks).The primary analysis consists in comparing inflammation markers and related risk factors between the two treatments. The study is designed to detect a 12-16% difference in plasma CRP concentrations (the primary endpoint) between the control and the dairy diet.
A 2-week stabilization run-in period will precede the randomization of participants. During this run-in period, participants will be asked and instructed to adapt their diet to a prudent dietary pattern low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). The total amount of fat in the diet will not be restricted, with recommendations ranging from 25-35% of energy. However, substitution of saturated for unsaturated fat will be advocated. Sodium intake <2300 mg/d will also be recommended. Recommendations will also include advice on how to restrict the consumption of processed and energy dense foods. The run-in diet will not include specific recommendation on dairy products. Participants will have the choice to include/exclude dairy from their prudent diet, as long as they comply with the main dietary recommendations. This 2-week run-in period will allow participants to familiarize themselves with the dietary recommendations used during the intervention per se. The two diets will be separated by a 4-week wash out period and will also consist to the prudent dietary pattern recommended. It must be stressed that foods will not be provided during the run-in and wash-out periods. These periods are imposed to minimize the inter- and intra-individual variability before and between the experimental phases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy diet | Experimental | Other: Dairy |
| Control diet | Placebo comparator | Other: Dairy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 70 years
- Presenting a subclinical inflammation (Plasma CRP >2 and <10 mg/l)
- Abdominal obesity, waist girth >94 cm in men and >80 cm in women
- Consumption of dairy products fewer than 2 servings per day
- Pre-menopausal women with regular menstrual cycle for the last 3 months
Key exclusion criteria (12 listed)
- Plasma CRP <2 or >10 mg/l
- Smokers (>1 cigarette/day)
- Body weight variation >10% for the last 6 months prior to the study baseline
- BMI >35 kg/m2
- Previous history of CVD, type 2 diabetes and monogenic dyslipidemia
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 |
|---|---|---|
| DairyAlso: Dairy products, milk, cheese, yogourtDuring the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (375 ml of milk, 175 g of yogurt, 30 g of cheese) into their every day diet. During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products (375 ml of fruit juice, 1 homemade cookie, 20 g of cashew). | Other | Control diet, Dairy diet |
Primary outcome
Change in plasma CRP concentrations
Time frame: At the beginning of the study and the end of the two 4-week diets
6 secondary outcomes
Change in endothelial function
Time frame: At the end of the two 4-week diets
Change in plasma lipid concentrations (LDL-Cholesterol, HDL-C, triglycerides)
Time frame: At the beginning of the study and the end of the two 4-week diets
Change in insulin levels
Time frame: At the beginning of the study and the end of the two 4-week diets
Change in anthropometric measures (waist and hip circumferences)
Time frame: At the beginning of the study and the end of the two 4-week diets
Change in blood pressure
Time frame: At the begining of the study and the end of the two 4-week diets
Change in CRP intravascular kinetics (in a subsample of the entire study population)
Time frame: At the end of the two 4-week diets
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 2 Apr 2014.
- Derived from this study: PubMed 27052530Abdullah MM, Cyr A, Lepine MC, Eck PK, Couture P, Lamarche B, Jones PJ. Common Variants in Cholesterol Synthesis- and Transport-Related Genes Associate with Circulating Cholesterol Responses to Intakes of Conventional Dairy Products in Healthy Individuals. J Nutr. 2016 May;146(5):1008-16. doi: 10.3945/jn.115.222208. Epub 2016 Apr 6.
- Derived from this study: PubMed 25332474Labonte ME, Cyr A, Abdullah MM, Lepine MC, Vohl MC, Jones P, Couture P, Lamarche B. Dairy product consumption has no impact on biomarkers of inflammation among men and women with low-grade systemic inflammation. J Nutr. 2014 Nov;144(11):1760-7. doi: 10.3945/jn.114.200576. Epub 2014 Sep 3.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy in people with Cardiovascular Disease, 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 5 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 2 Apr 2014. 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. Some participants in this study may receive a placebo. 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 plasma CRP concentrations (time frame: At the beginning of the study and the end of the two 4-week diets). 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 NCT01444326, 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 2 Apr 2014.