Blood Pressure and Glucose Lowering Diet for Taiwanese (Taiwan_DASH)

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: DASH diet; Other: lower carbohydrate DASH diet

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Miaoli County, Taiwan
    • National Health Research Institutes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	Baseline and per week after intervention	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Wen-Han Pan, Ph. D., National Health Research Institutes, Taiwan

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Estimate): June 2, 2011
• Last Update Submitted That Met QC Criteria: June 1, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: EC0990602-E