Blood Pressure and Glucose Lowering Diet for Taiwanese

Hypertension Clinical Trial

— Taiwan_DASH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01364337
• Other study ID #: EC0990602-E
• Status: Active, not recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 1, 2011
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• lower carbohydrate DASH diet
lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage

Locations

Country	Name	City	State
Taiwan	National Health Research Institutes	Miaoli County

Sponsors (2)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	Baseline and per week after intervention	4 weeks	No
Secondary	Fasting blood glucose, fasting insulin, cholesterol, triglycerides, HDL-C and LDL-C		will be measured at 0, 2, 4, 8, 10 and 12 weeks	No
Secondary	Urinary magnesium, potassium, sodium and creatinine		will be measured at 0, 2, 4, 8, 10 and 12 weeks	No