Blood Pressure and Glucose Lowering Diet for Taiwanese

NCT ID: NCT01364337

Last Updated: 2011-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DASH diet

Group Type: ACTIVE_COMPARATOR

DASH diet

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

lower carbohydrate DASH diet

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

lower carbohydrate DASH diet

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

National Health Research Institutes, Taiwan

Principal Investigators

Wen-Han Pan, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Locations

National Health Research Institutes

Miaoli County, , Taiwan

Countries

Taiwan

Other Identifiers

EC0990602-E

Identifier Type: -

Identifier Source: org_study_id