Blood Pressure and Glucose Lowering Diet for Taiwanese | NCT01364337

Studies
Blood Pressure and Glucose Lowering Diet for Taiwanese

NCT01364337

Sponsor

National Health Research Institutes, Taiwan

Status

Unknown status

Last Update Posted

Jun 2, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hypertension

Interventions

DASH diet
lower carbohydrate DASH diet

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

May 31, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2011

Last Update Posted Date

Jun 2, 2011Estimated

Name	Class
Taipei Veterans General Hospital, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DASH diet	Active Comparator		Other: DASH diet
lower carbohydrate DASH diet	Active Comparator		Other: lower carbohydrate DASH diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DASH diet	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.	DASH diet

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747