PrehypertensionNCT01577030
Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
A study testing Non-fat dairy and Add 4 servings fruit in people with Prehypertension and Stage-1 Hypertension, run by University of Texas at Austin at 1 site in United States.
Trial summary
Elevated systolic blood pressure is by far the largest single contributor to cardiovascular risks in middle-aged and older adults. Lifestyle modifications, including dietary modifications, are the first line approach for treating and preventing hypertension. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Prehypertension, Stage-1 Hypertension
- What is being tested?
- Non-fat dairy and Add 4 servings fruit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 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 35 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, Cardiovascular Aging Research Laboratory
Austin, Texas, 78712
About this study
Elevated systolic blood pressure is by far the largest single contributor to cardiovascular risks in middle-aged and older adults. Lifestyle modifications, including dietary modifications, are the first line approach for treating and preventing hypertension. The general aim of the proposed study is to address the efficacy of conventional dairy products as part of the normal routine diet for lowing arterial blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that the dietary intervention including dairy products will induce significant decreases in arterial blood pressure in this population. A secondary aim will be to test the hypothesis that these reductions in systolic blood pressure will be associated with increases in arterial stiffness/compliance and endothelial vasodilatory function.
- Conditions
- Prehypertension, Stage-1 Hypertension
- Being tested
- Non-fat dairy, Add 4 servings fruit
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-fat dairyDietary supplement
Add 4 daily servings per day of non-fat dairy (yogurt, milk, cheese) for a period of 4 weeks
Add 4 servings fruitDietary supplement
Add 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and remove all dairy for a period for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dairy | Experimental | Add 4 daily servings of non-fat dairy to diet for a period of 4 weeks Receives: Dietary Supplement: Non-fat dairy |
| Fruit | Active comparator | Add 4 daily servings of fruit to diet, remove all dairy from diet for a period of 4 weeks Receives: Dietary Supplement: Add 4 servings fruit |
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
Measured: 4 weeks
Arterial stiffness
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 posted13 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionNov 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 PrehypertensionStudies 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
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hirofumi Tanaka, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577030
- Sponsor's protocol ID
- LH002
- Status last verified
- Feb 2014
- First submitted
- 10 Apr 2012
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Effects of non-fat dairy products added to the routine diet on vascular function: a randomized controlled crossover trial. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):364-9. doi: 10.1016/j.numecd.2015.01.005. Epub 2015 Jan 31.
PubMed 25770758Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Hypotensive effects of solitary addition of conventional nonfat dairy products to the routine diet: a randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):80-7. doi: 10.3945/ajcn.114.085761. Epub 2014 May 7.
PubMed 24808486
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
- ClinicalTrials.gov ID
- NCT01577030
- Acronym / sponsor ID
- LH002
- Conditions
- Prehypertension, Stage-1 Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Apr 2012 (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.
Elevated systolic blood pressure is by far the largest single contributor to cardiovascular risks in middle-aged and older adults. Lifestyle modifications, including dietary modifications, are the first line approach for treating and preventing hypertension. The general aim of the proposed study is to address the efficacy of conventional dairy products as part of the normal routine diet for lowing arterial blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that the dietary intervention including dairy products will induce significant decreases in arterial blood pressure in this population. A secondary aim will be to test the hypothesis that these reductions in systolic blood pressure will be associated with increases in arterial stiffness/compliance and endothelial vasodilatory function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy | Experimental | Dietary Supplement: Non-fat dairyAdd 4 daily servings of non-fat dairy to diet for a period of 4 weeks |
| Fruit | Active comparator | Dietary Supplement: Add 4 servings fruitAdd 4 daily servings of fruit to diet, remove all dairy from diet for a period of 4 weeks |
Who may qualify
- Ages
- 35 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 |
|---|---|---|
| Non-fat dairyAdd 4 daily servings per day of non-fat dairy (yogurt, milk, cheese) for a period of 4 weeks | Dietary supplement | Dairy |
| Add 4 servings fruitAdd 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and remove all dairy for a period for 4 weeks | Dietary supplement | Fruit |
Primary outcome
Seated blood pressure
Time frame: 4 weeks
4 secondary outcomes
24-hour ambulatory blood pressure
Time frame: 4 weeks
Carotid arterial compliance
Time frame: 4 weeks
Arterial stiffness
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 12 Feb 2014.
- Derived from this study: PubMed 25770758Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Effects of non-fat dairy products added to the routine diet on vascular function: a randomized controlled crossover trial. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):364-9. doi: 10.1016/j.numecd.2015.01.005. Epub 2015 Jan 31.
- Derived from this study: PubMed 24808486Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Hypotensive effects of solitary addition of conventional nonfat dairy products to the routine diet: a randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):80-7. doi: 10.3945/ajcn.114.085761. Epub 2014 May 7.
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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.
Hirofumi Tanaka, PhD principal investigator
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 Non-fat dairy and Add 4 servings fruit in people with Prehypertension and Stage-1 Hypertension, 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 12 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 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?
On the ClinicalTrials.gov record for NCT01577030, 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 12 Feb 2014.