HypertensionTaiwan_DASHNCT01364337
Blood Pressure and Glucose Lowering Diet for Taiwanese
A study testing DASH diet and lower carbohydrate DASH diet in people with Hypertension, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly prescribed with medications without comprehensive instructions on dietary therapy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- DASH diet and lower carbohydrate DASH diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2010to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-65 years, weight 50-80 kg(±5kg)
- Two blood pressure readings and fasting blood glucose measurements:
- fasting blood glucose of 100-125 ml/dL and not using antidiabetic medication.
- systolic blood pressure of 130-159 mmHg or diastolic blood pressure of 85-99 mmHg and not using antihypertensive medication.
Who cannot join
- (a) taking blood glucose lowering, antihypertensive or oral steroid medications.
- history of stroke, cardiovascular disease, abnormal liver function, cancer, stomach ulcer, inflammatory bowel disease or other chronic diseases that will influence the diet of participants.
- Major surgery in the past year or about to undergo major surgery.
- Is the holder of a major illness card.
- Takes antipsychotics.
- Harmful drinker (more than 14 drinks per week)
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- Has food allergies or food intolerance.
- Pregnant or breastfeeding.
- Unwilling to cease intake of vitamin or mineral supplements or antacids containing magnesium or calcium for the duration of the study.
- Other medications or physiological states influencing the absorption of nutrients.
- Other individuals deemed unsuitable to participate in the intervention by their treating physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Testing Efficacy of Blood Pressure and Glucose Lowering Diet for Taiwanese Pre-/1st Staged Hypertension Patients and/or Pre-diabetes Patients
Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly prescribed with medications without comprehensive instructions on dietary therapy. DASH diet has been proven to be an effective dietary approach to reduce blood pressure for hypertension patients in US. However, dietary difference and patient profiles across countries are evident. In addition, hypertensive patients are often combined with hyperglycemia. Carbohydrate burden of DASH diet may be higher than most dietitians desire. Therefore, the investigators in tend to design a Taiwanese DASH diet and a lower carbohydrate DASH diet and test their efficacy on both blood pressure and fasting glucose lowering.
- Conditions
- Hypertension
- Being tested
- DASH diet, lower carbohydrate DASH diet
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietOther
DASH diet: A diet rich in whole grain, fruit and vegetable, low-fat dairy products, white meat and nuts; and lower of total fat and saturated fat.
lower carbohydrate DASH dietOther
lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage
| Study group | Role | What they receive |
|---|---|---|
| DASH diet | Active comparator | Not described Receives: Other: DASH diet |
| lower carbohydrate DASH diet | Active comparator | Not described Receives: Other: lower carbohydrate DASH diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Baseline and per week after intervention
Measured: 4 weeks
Secondary outcomes (2)
Fasting blood glucose, fasting insulin, cholesterol, triglycerides, HDL-C and LDL-C
Measured: will be measured at 0, 2, 4, 8, 10 and 12 weeks
Urinary magnesium, potassium, sodium and creatinine
Measured: will be measured at 0, 2, 4, 8, 10 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Investigators
- Wen-Han Pan, Ph. D., Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364337
- Sponsor's protocol ID
- EC0990602-E
- Acronym
- Taiwan_DASH
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Testing Efficacy of Blood Pressure and Glucose Lowering Diet for Taiwanese Pre-/1st Staged Hypertension Patients and/or Pre-diabetes Patients
- ClinicalTrials.gov ID
- NCT01364337
- Acronym / sponsor ID
- Taiwan_DASH / EC0990602-E
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Jun 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.
Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly prescribed with medications without comprehensive instructions on dietary therapy. DASH diet has been proven to be an effective dietary approach to reduce blood pressure for hypertension patients in US. However, dietary difference and patient profiles across countries are evident. In addition, hypertensive patients are often combined with hyperglycemia. Carbohydrate burden of DASH diet may be higher than most dietitians desire. Therefore, the investigators in tend to design a Taiwanese DASH diet and a lower carbohydrate DASH diet and test their efficacy on both blood pressure and fasting glucose lowering.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH diet | Active comparator | Other: DASH diet |
| lower carbohydrate DASH diet | Active comparator | Other: lower carbohydrate DASH diet |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-65 years, weight 50-80 kg(±5kg)
- Two blood pressure readings and fasting blood glucose measurements:
Key exclusion criteria (11 listed)
- (a) taking blood glucose lowering, antihypertensive or oral steroid medications.
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 |
|---|---|---|
| DASH dietDASH diet: A diet rich in whole grain, fruit and vegetable, low-fat dairy products, white meat and nuts; and lower of total fat and saturated fat. | Other | DASH diet |
| lower carbohydrate DASH dietlower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage | Other | lower carbohydrate DASH diet |
Primary outcome
blood pressure
Time frame: 4 weeks
Baseline and per week after intervention
2 secondary outcomes
Fasting blood glucose, fasting insulin, cholesterol, triglycerides, HDL-C and LDL-C
Time frame: will be measured at 0, 2, 4, 8, 10 and 12 weeks
Urinary magnesium, potassium, sodium and creatinine
Time frame: will be measured at 0, 2, 4, 8, 10 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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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.
Wen-Han Pan, Ph. D. principal investigator
National Health Research Institutes, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH diet and lower carbohydrate DASH diet in people with Hypertension, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 11 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 2 Jun 2011. 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 Taiwan. 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?
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?
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 2 Jun 2011.