HypertensionPLATNCT01776216
Impact of Dairy Consumption on Hypertension: a Clinical Study
A study testing Dairy diet in people with Hypertension and Cardiovascular Diseases, run by Laval University at 1 site in Canada.
Trial summary
Hypertension 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 years
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- Dairy diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 70 years
- Mean daytime systolic blood pressure ≥ 135 mm Hg and ≤ 160 mm Hg
- Mean daytime diastolic blood pressure ≤ 110 mm Hg
- Consumption of dairy products fewer than 2 servings per day
Who cannot join
- Mean daytime systolic blood pressure > 160 mm Hg
- Mean daytime diastolic blood pressure > 110 mm Hg
- Dairy intake > 2 serving per day
- Smokers (>1 cigarette/day)
- Body weight variation >10% during the last 6 months prior to the study baseline
- BMI >35 kg/m2
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- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subject taking anti-inflammatory drugs
- Subject with endocrine or gastrointestinal disorders
- Allergy, intolerance or aversion to dairy
- Clinical use of vitamin D or calcium supplements
- Vegetarians
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceuticals and Functional Foods (INAF)
Québec, Quebec, G1V 0A6
About this study
Official title: Impact of Dairy Consumption on Hypertension: a Clinical Study.
Hypertension and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). A substantial body of evidence indicates that treating patients with elevated blood pressure (BP) leads to marked reduction in the risk of stroke, myocardial infarction, heart failure, and renal failure. There is also accumulating evidence associating endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to elevated BP and an increased risk of CVD.
While there are more and more studies on how diet affects BP in healthy subjects, the impact of dairy consumption per se on both endothelial function and ambulatory BP has not been well characterized in patients with established essential hypertension. Therefore, the general objective of the study is to investigate in a single-blind randomized controlled study the impact of dairy consumption on ambulatory BP and endothelial function in subjects with mild to moderate essential hypertension.
Read the detailed description
The proposed research will be undertaken as a single-center randomized cross-over controlled study. A total of 80 men and women with mild to moderate essential hypertension but otherwise healthy will consume two 4-week 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. The primary analysis consists in comparing mean daytime ambulatory BP values and endothelial function between the two treatments.
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. 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
- Hypertension, Cardiovascular Diseases
- Being tested
- Dairy diet, Control diet
- Keywords
- Endothelial function, Dairy
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy dietOther
Also called Dairy products, Milk, Yogourt, Cheese
During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy: 375 ml of reduced fat milk (1% fat), 175 g of low fat yogurt (1.5% fat) and 30g of regular cheese (34% fat) into their every day diet.
Control dietOther
During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products (290 ml of fruit juice, 156 ml of vegetable juice, 1 homemade cookie, 20g of cashew).
| Study group | Role | What they receive |
|---|---|---|
| Dairy diet | Experimental | During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy into their everyday diet. Receives: Other: Dairy diet |
| Control diet | Placebo comparator | During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products into their everyday diet. Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean daytime systolic blood pressure
Mean daytime systolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)
Measured: At the fisrt visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)
Secondary outcomes (2)
Change in mean daytime diastolic blood pressure
Mean daytime diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)
Measured: At the first visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)
Change in endothelial function
Digital pulse amplitude will be measured with a PAT device placed on the tip of each index finger (Endo-PAT2000, Itamar Medical, Caesarea, Israel)
Measured: At the end of the two 4-weeks diets (week 4 and week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionDec 2013
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 HypertensionStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD,FRCP,PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776216
- Sponsor's protocol ID
- INAF-C11-02-163
- Acronym
- PLAT
- Status last verified
- Feb 2014
- First submitted
- 21 Jan 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Drouin-Chartier JP, Gigleux I, Tremblay AJ, Poirier L, Lamarche B, Couture P. Impact of dairy consumption on essential hypertension: a clinical study. Nutr J. 2014 Aug 14;13:83. doi: 10.1186/1475-2891-13-83.
PubMed 25123170
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dairy Consumption on Hypertension: a Clinical Study.
- ClinicalTrials.gov ID
- NCT01776216
- Acronym / sponsor ID
- PLAT / INAF-C11-02-163
- Conditions
- Hypertension, Cardiovascular Diseases
- Keywords
- Endothelial function, Dairy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jan 2013 (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.
Hypertension and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). A substantial body of evidence indicates that treating patients with elevated blood pressure (BP) leads to marked reduction in the risk of stroke, myocardial infarction, heart failure, and renal failure. There is also accumulating evidence associating endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to elevated BP and an increased risk of CVD.
While there are more and more studies on how diet affects BP in healthy subjects, the impact of dairy consumption per se on both endothelial function and ambulatory BP has not been well characterized in patients with established essential hypertension. Therefore, the general objective of the study is to investigate in a single-blind randomized controlled study the impact of dairy consumption on ambulatory BP and endothelial function in subjects with mild to moderate essential hypertension.
Detailed description
The proposed research will be undertaken as a single-center randomized cross-over controlled study. A total of 80 men and women with mild to moderate essential hypertension but otherwise healthy will consume two 4-week 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. The primary analysis consists in comparing mean daytime ambulatory BP values and endothelial function between the two treatments.
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. 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy diet | Experimental | Other: Dairy dietDuring the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy into their everyday diet. |
| Control diet | Placebo comparator | Other: Control dietDuring the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products into their everyday diet. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 18 and 70 years
- Mean daytime systolic blood pressure ≥ 135 mm Hg and ≤ 160 mm Hg
- Mean daytime diastolic blood pressure ≤ 110 mm Hg
- Consumption of dairy products fewer than 2 servings per day
Key exclusion criteria (12 listed)
- Mean daytime systolic blood pressure > 160 mm Hg
- Mean daytime diastolic blood pressure > 110 mm Hg
- Dairy intake > 2 serving per day
- Smokers (>1 cigarette/day)
- Body weight variation >10% during the last 6 months prior to the study baseline
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 |
|---|---|---|
| Dairy dietAlso: Dairy products, Milk, Yogourt, CheeseDuring the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy: 375 ml of reduced fat milk (1% fat), 175 g of low fat yogurt (1.5% fat) and 30g of regular cheese (34% fat) into their every day diet. | Other | Dairy diet |
| Control dietDuring the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products (290 ml of fruit juice, 156 ml of vegetable juice, 1 homemade cookie, 20g of cashew). | Other | Control diet |
Primary outcome
Change in mean daytime systolic blood pressure
Time frame: At the fisrt visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)
Mean daytime systolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)
2 secondary outcomes
Change in mean daytime diastolic blood pressure
Time frame: At the first visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)
Change in endothelial function
Time frame: At the end of the two 4-weeks diets (week 4 and week 12)
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 7 Feb 2014.
- Derived from this study: PubMed 25123170Drouin-Chartier JP, Gigleux I, Tremblay AJ, Poirier L, Lamarche B, Couture P. Impact of dairy consumption on essential hypertension: a clinical study. Nutr J. 2014 Aug 14;13:83. doi: 10.1186/1475-2891-13-83.
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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,FRCP,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 diet in people with Hypertension and Cardiovascular Diseases, 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 4 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 7 Feb 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 mean daytime systolic blood pressure (time frame: At the fisrt visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)). 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 NCT01776216, 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 7 Feb 2014.