Clinical trial NCT01364337: Blood Pressure and Glucose Lowering Diet for Taiwanese
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2011-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: blood pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: Fasting blood glucose, fasting insulin, cholesterol, triglycerides, HDL-C and LDL-C
timeFrame: will be measured at 0, 2, 4, 8, 10 and 12 weeks
measure: Urinary magnesium, potassium, sodium and creatinine
timeFrame: will be measured at 0, 2, 4, 8, 10 and 12 weeks
Other outcomes:
Locations:
city: Miaoli County
country: Taiwan
facility: National Health Research Institutes
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Wen-Han Pan, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: