HypertensionNCT01463085
Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
A study testing Low-fat dairy in people with Hypertension, run by Dairy Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Low-fat dairy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2012
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a female or male, 20-69 years of age, inclusive.
- Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive.
- Subject has resting blood pressure measurements meeting the criteria for pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1 hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg)
- Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
- Subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
- Subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.
Who cannot join
- Subject has known coronary heart disease (CHD) or a CHD risk equivalent
- Subject has a history of any major trauma or major surgical event
- Subject has digital deformities that would prevent EndoPAT measurements.
- Subject has used medications known to alter body weight
- Subject has used medications or dietary supplements that, in the opinion of the Investigator, have strong potential to influence blood pressure or endothelial function
- Subject has extreme dietary habits (e.g., Atkins diet, very high protein/low carbohydrate).
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis - Provident Clinical Research
Glen Ellyn, Illinois, 60137
About this study
Official title: A Randomized, Controlled, Trial to Assess the Effects of Low-fat Dairy Intake on Endothelial Function and Blood Pressure in Subjects With Pre-hypertension or Stage 1 Hypertension
The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension.
- Conditions
- Hypertension
- Being tested
- Low-fat dairy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dairyOther
Dietary Intervention of 3 servings per day of low-fat dairy
| Study group | Role | What they receive |
|---|---|---|
| Control foods | Placebo comparator | 3 servings per day of control foods Receives: Other: Low-fat dairy |
| Low-fat dairy | Experimental | 3 servings per day of low-fat dairy products Receives: Other: Low-fat dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.
Measured: 5 weeks
Secondary outcomes (1)
Vascular function
Subjects will be fasted overnight and endothelial function will be determined using the EndoPAT System according to the manufacturer's instructions. The measurements will occur in the index fingers of both hands, simultaneously and will be taken with subjects in a sitting position while in a quiet, thermo- neutral room.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dairy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- BioFortis, Provident Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, Biofortis - Provident Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463085
- Sponsor's protocol ID
- PRV-11022
- Status last verified
- May 2012
- First submitted
- 27 Oct 2011
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Trial to Assess the Effects of Low-fat Dairy Intake on Endothelial Function and Blood Pressure in Subjects With Pre-hypertension or Stage 1 Hypertension
- ClinicalTrials.gov ID
- NCT01463085
- Acronym / sponsor ID
- PRV-11022
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Dairy Research InstituteUniversity, hospital or other
- Collaborators
- BioFortis, Provident Clinical Research
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 1 Nov 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.
The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control foods | Placebo comparator | Other: Low-fat dairy3 servings per day of control foods |
| Low-fat dairy | Experimental | Other: Low-fat dairy3 servings per day of low-fat dairy products |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is a female or male, 20-69 years of age, inclusive.
- Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive.
- Subject has resting blood pressure measurements meeting the criteria for pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1 hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg)
- Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
- Subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
Key exclusion criteria (6 listed)
- Subject has known coronary heart disease (CHD) or a CHD risk equivalent
- Subject has a history of any major trauma or major surgical event
- Subject has digital deformities that would prevent EndoPAT measurements.
- Subject has used medications known to alter body weight
- Subject has used medications or dietary supplements that, in the opinion of the Investigator, have strong potential to influence blood pressure or endothelial function
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 |
|---|---|---|
| Low-fat dairyDietary Intervention of 3 servings per day of low-fat dairy | Other | Control foods, Low-fat dairy |
Primary outcome
Systolic blood pressure
Time frame: 5 weeks
Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.
1 secondary outcome
Vascular function
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
Kevin C Maki, PhD study director
Biofortis - Provident Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat dairy in people with Hypertension, run by Dairy Research Institute at 1 site in United States.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 May 2012. 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 United States. 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?
Results are not available in the source record.
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?
Systolic blood pressure (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2012.