HypertensionNCT02397902
Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
A study testing High fat dairy and Plant-based in people with Hypertension and Prehypertension, run by University of Texas at Austin at 1 site in United States.
Trial summary
The specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension, Prehypertension
- What is being tested?
- High fat dairy and Plant-based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 30 Jan 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prehypertension or stage-1 hypertension
Who cannot join
- Consume > 3 servings of dairy or fruit per day
- Strenuous physical activity > 3 time per week
- Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
- Taking cardiovascular-acting drugs
- Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
The specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that dietary intervention including whole milk and full-fat milk products will induce significant decreases in systolic blood pressure and arterial stiffness. The investigators also test the hypothesis that the reductions in blood pressure will be associated with the corresponding decreases in arterial stiffness and/or increases in endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity. If our hypotheses are supported by the results, the information could be used as a basis for recommendations for the use of whole milk and full-fat milk products in the secondary prevention of elevated blood pressure and vascular dysfunction.
- Conditions
- Hypertension, Prehypertension
- Being tested
- High fat dairy, Plant-based
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat dairyDietary supplement
Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks
Plant-basedDietary supplement
Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dairy | Experimental | Add 4 daily servings of high fat dairy to diet for a period of 4 weeks Receives: Dietary Supplement: High fat dairy |
| Plant-based | Active comparator | Add 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks Receives: Dietary Supplement: Plant-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated blood pressure
Measured: 4 weeks
Secondary outcomes (4)
24-hour ambulatory blood pressure
Measured: 4 weeks
Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound
Measured: 4 weeks
Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery
Measured: 4 weeks
Flow mediated dilation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
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.
- More trials run by University of Texas at AustinThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Principal investigator, Stephen J. Roy, University of Texas at Austin
- Investigators
- Tanaka Hirofumi, PhD, Principal investigator, The University of Texas at AustinStephen J Roy, MS, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397902
- Sponsor's protocol ID
- UTexasAustin
- Status last verified
- Jan 2018
- First submitted
- 16 Mar 2015
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
- ClinicalTrials.gov ID
- NCT02397902
- Acronym / sponsor ID
- UTexasAustin
- Conditions
- Hypertension, Prehypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Mar 2015
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 25 Mar 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.
The specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that dietary intervention including whole milk and full-fat milk products will induce significant decreases in systolic blood pressure and arterial stiffness. The investigators also test the hypothesis that the reductions in blood pressure will be associated with the corresponding decreases in arterial stiffness and/or increases in endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity. If our hypotheses are supported by the results, the information could be used as a basis for recommendations for the use of whole milk and full-fat milk products in the secondary prevention of elevated blood pressure and vascular dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy | Experimental | Dietary Supplement: High fat dairyAdd 4 daily servings of high fat dairy to diet for a period of 4 weeks |
| Plant-based | Active comparator | Dietary Supplement: Plant-basedAdd 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prehypertension or stage-1 hypertension
Key exclusion criteria (5 listed)
- Consume > 3 servings of dairy or fruit per day
- Strenuous physical activity > 3 time per week
- Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
- Taking cardiovascular-acting drugs
- Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease
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 |
|---|---|---|
| High fat dairyAdd 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks | Dietary supplement | Dairy |
| Plant-basedAdd 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks | Dietary supplement | Plant-based |
Primary outcome
Seated blood pressure
Time frame: 4 weeks
4 secondary outcomes
24-hour ambulatory blood pressure
Time frame: 4 weeks
Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound
Time frame: 4 weeks
Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery
Time frame: 4 weeks
Flow mediated dilation
Time frame: 4 weeks
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 1 Feb 2018.
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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.
Tanaka Hirofumi, PhD principal investigator
The University of Texas at Austin
Stephen J Roy, MS principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat dairy and Plant-based in people with Hypertension and Prehypertension, run by University of Texas at Austin 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 1 inclusion and 5 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 1 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 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. 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?
Seated blood pressure (time frame: 4 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 1 Feb 2018.