Blood Pressure and Glucose Lowering Diet for Taiwanese (Taiwan_DASH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Health Research Institutes, Taiwan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01364337
First received: May 31, 2011
Last updated: June 1, 2011
Last verified: May 2011

May 31, 2011
June 1, 2011
November 2010
December 2011   (final data collection date for primary outcome measure)
blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Baseline and per week after intervention
Same as current
Complete list of historical versions of study NCT01364337 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Urinary magnesium, potassium, sodium and creatinine [ Time Frame: will be measured at 0, 2, 4, 8, 10 and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Blood Pressure and Glucose Lowering Diet for Taiwanese
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypertension
  • 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.
  • Other: lower carbohydrate DASH diet
    lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage
  • Active Comparator: DASH diet
    Intervention: Other: DASH diet
  • Active Comparator: lower carbohydrate DASH diet
    Intervention: Other: lower carbohydrate DASH diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2011
December 2011   (final data collection date for primary outcome measure)

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.

Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01364337
EC0990602-E
No
Wen-Harn Pan, Principal investigator, National Health Research Institutes, Taiwan
National Health Research Institutes, Taiwan
Taipei Veterans General Hospital, Taiwan
Principal Investigator: Wen-Han Pan, Ph. D. National Health Research Institutes, Taiwan
National Health Research Institutes, Taiwan
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP