Overview

This trial is active, not recruiting.

Condition hypertension
Treatments dash diet, lower carbohydrate dash diet
Sponsor National Health Research Institutes, Taiwan
Collaborator Taipei Veterans General Hospital, Taiwan
Start date November 2010
End date December 2011
Trial size 50 participants
Trial identifier NCT01364337, EC0990602-E

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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
lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage

Primary Outcomes

Measure
blood pressure
time frame: 4 weeks

Secondary Outcomes

Measure
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
Urinary magnesium, potassium, sodium and creatinine
time frame: will be measured at 0, 2, 4, 8, 10 and 12 weeks

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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.

Additional Information

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
Principal investigator Wen-Han Pan, Ph. D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by National Health Research Institutes, Taiwan.