Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

November 20, 2023 updated by: Taipei Medical University Hospital

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Djulis-Buckwheat & Placebo
Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks
Dietary supplement: Placebo
Ingest placebo drink 100ml/day for 8 weeks
Dietary supplement: Djulis-Buckwheat
Ingest Djulis-Buckwheat drink 100ml/day for 8 weeks
Active Comparator: Buckwheat & Placebo
Ingest Buckwheat or placebo drink 100ml/day for 8 weeks
Dietary supplement: Placebo
Ingest placebo drink 100ml/day for 8 weeks
Dietary supplement: Buckwheat
Ingest Buckwheat drink 100ml/day for 8 weeks
Experimental: Djulis-Buckwheat & Buckwheat
Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks
Dietary supplement: Djulis-Buckwheat
Ingest Djulis-Buckwheat drink 100ml/day for 8 weeks
Dietary supplement: Buckwheat
Ingest Buckwheat drink 100ml/day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of blood pressure
Time Frame: Baseline, 1, 2, 4, 6, and 8 weeks
Baseline, 1, 2, 4, 6, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2019

Primary Completion (Estimated)

January 1, 2020

Study Completion (Estimated)

December 1, 2020

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimated)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201604003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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