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Blood Pressure and Glucose Lowering Diet for Taiwanese (Taiwan_DASH)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
DASH diet
lower carbohydrate DASH diet
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Health Research Institutes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DASH diet

lower carbohydrate DASH diet

Arm Description

Outcomes

Primary Outcome Measures

blood pressure
Baseline and per week after intervention

Secondary Outcome Measures

Fasting blood glucose, fasting insulin, cholesterol, triglycerides, HDL-C and LDL-C
Urinary magnesium, potassium, sodium and creatinine

Full Information

First Posted
May 31, 2011
Last Updated
June 1, 2011
Sponsor
National Health Research Institutes, Taiwan
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01364337
Brief Title
Blood Pressure and Glucose Lowering Diet for Taiwanese
Acronym
Taiwan_DASH
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

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Health Research Institutes, Taiwan
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DASH diet
Arm Type
Active Comparator
Arm Title
lower carbohydrate DASH diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
DASH diet
Intervention Description
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
Intervention Name(s)
lower carbohydrate DASH diet
Intervention Description
lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage
Primary Outcome Measure Information:
Title
blood pressure
Description
Baseline and per week after intervention
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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
Title
Urinary magnesium, potassium, sodium and creatinine
Time Frame
will be measured at 0, 2, 4, 8, 10 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Han Pan, Ph. D.
Organizational Affiliation
National Health Research Institutes, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Research Institutes
City
Miaoli County
Country
Taiwan

12. IPD Sharing Statement

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Blood Pressure and Glucose Lowering Diet for Taiwanese

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