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NCT02825901 Clinical Trial

Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

Prehypertension Clinical Trial

Official title:
Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02825901
Other study ID # N201604003
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2019
Est. completion date December 2020

Study information
Verified date March 2018
Source Taipei Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the trial is to evaluate the effect of Djulis-Buckwheat drink on cardiovascular protection after ingesting for 8 weeks. In addition, the correlation between the supplement and the cardiovascular disease-related gene expression is evaluated. The results will be used for the application of functional products for cardiovascular protection. Ninety subjects (age 30~65) with Prehypertension or Hypertension stage 1 will be included and randomly allocated into 3 groups: Placebo, Djulis-Buckwheat and Buckwheat. The subjects will take sample (100 ml/day) for 8 weeks. Blood pressure will be measured on week 0, 1, 2, 4, 6 and 8. The blood biochemical parameters and gene expression analysis will be examined on week 2, 4, 6, 8 and 10 (the follow up).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - Systolic blood pressure 121-159 mmHg or Diastolic blood pressure 81-99 mmHg - Age: 30-65 Exclusion Criteria: - Have diagnosed and documented critical illness(NHI specification) - Had emergency record or admission note in the past three months - Not be pregnant or breast-feeding a child

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Placebo
Ingest placebo drink 100ml/day for 8 weeks
• Djulis-Buckwheat
Ingest Djulis-Buckwheat drink 100ml/day for 8 weeks
• Buckwheat
Ingest Buckwheat drink 100ml/day for 8 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taipei Medical University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Change of blood pressure Baseline, 1, 2, 4, 6, and 8 weeks
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