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Blood Pressure and Glucose Lowering Diet for Taiwanese (Taiwan_DASH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by National Health Research Institutes, Taiwan.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364337
First Posted: June 2, 2011
Last Update Posted: June 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by:
National Health Research Institutes, Taiwan
  Purpose
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.

Condition Intervention
Hypertension Other: DASH diet Other: lower carbohydrate DASH diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 4 weeks ]
    Baseline and per week after intervention


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DASH diet Other: DASH diet
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.
Active Comparator: lower carbohydrate DASH diet Other: lower carbohydrate DASH diet
lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20-65 years, weight 50-80 kg(±5kg)
  • Two blood pressure readings and fasting blood glucose measurements:

    1. fasting blood glucose of 100-125 ml/dL and not using antidiabetic medication.
    2. systolic blood pressure of 130-159 mmHg or diastolic blood pressure of 85-99 mmHg and not using antihypertensive medication.

Exclusion Criteria:

  • (a) taking blood glucose lowering, antihypertensive or oral steroid medications.

    (b) 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.

    (c) Major surgery in the past year or about to undergo major surgery.

    (d) Is the holder of a major illness card.

    (e) Takes antipsychotics.

    (f) Harmful drinker (more than 14 drinks per week)

    (g) Has food allergies or food intolerance.

    (h) Pregnant or breastfeeding.

    (i) Unwilling to cease intake of vitamin or mineral supplements or antacids containing magnesium or calcium for the duration of the study.

    (j) Other medications or physiological states influencing the absorption of nutrients.

    (k) Other individuals deemed unsuitable to participate in the intervention by their treating physician.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364337


Locations
Taiwan
National Health Research Institutes
Miaoli County, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Wen-Han Pan, Ph. D. National Health Research Institutes, Taiwan
  More Information

Responsible Party: Wen-Harn Pan, Principal investigator, National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01364337     History of Changes
Other Study ID Numbers: EC0990602-E
First Submitted: May 31, 2011
First Posted: June 2, 2011
Last Update Posted: June 2, 2011
Last Verified: May 2011

Keywords provided by National Health Research Institutes, Taiwan:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases