NCT01364337

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 2, 2011

Status Verified

May 1, 2011

Enrollment Period

1.1 years

First QC Date

May 31, 2011

Last Update Submit

June 1, 2011

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    Baseline and per week after intervention

    4 weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

DASH diet

ACTIVE COMPARATOR
Other: DASH diet

lower carbohydrate DASH diet

ACTIVE COMPARATOR
Other: lower carbohydrate DASH diet

Interventions

DASH dietOTHER

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
lower carbohydrate DASH dietOTHER

lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage

lower carbohydrate DASH diet

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Research Institutes

Miaoli County, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Wen-Han Pan, Ph. D.

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 2, 2011

Record last verified: 2011-05

Locations

TW(1)