Blood Pressure and Glucose Lowering Diet for Taiwanese

Study Overview
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Brief Summary
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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.

Official Title
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Design and Testing Efficacy of Blood Pressure and Glucose Lowering Diet for Taiwanese Pre-/1st Staged Hypertension Patients and/or Pre-diabetes Patients

Conditions
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Hypertension

Intervention / Treatment
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* Other: DASH diet
* Other: lower carbohydrate DASH diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-65 years, weight 50-80 kg(±5kg) Two blood pressure readings and fasting blood glucose measurements: fasting blood glucose of 100-125 ml/dL and not using antidiabetic medication. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DASH diet<br> | Other: DASH diet<br>* 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.<br>|
| Active Comparator: lower carbohydrate DASH diet<br> | Other: lower carbohydrate DASH diet<br>* lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension