Blood Pressure and Glucose Lowering Diet for Taiwanese

Not Applicable

• Conditions: Hypertension
• Interventions: Other: DASH diet; Other: lower carbohydrate DASH diet

• Registration Number: NCT01364337
• Lead Sponsor: National Health Research Institutes, Taiwan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Status Verified: 2011-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Last Update Submitted: 2011-06-01
• Study First Posted: 2011-06-02
• Last Update Posted: 2011-06-02
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DASH diet	DASH diet	-
lower carbohydrate DASH diet	lower carbohydrate DASH diet	-

Primary Outcome Measures

Name	Time	Method
blood pressure	4 weeks	Baseline and per week after intervention

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose, fasting insulin, cholesterol, triglycerides, HDL-C and LDL-C	will be measured at 0, 2, 4, 8, 10 and 12 weeks
Urinary magnesium, potassium, sodium and creatinine	will be measured at 0, 2, 4, 8, 10 and 12 weeks

Trial Locations

Locations (1)

National Health Research Institutes; 🇨🇳 Miaoli County, Taiwan