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Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

Primary Purpose

Prehypertension, Hypertension Stage 1

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Djulis-Buckwheat
Buckwheat
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehypertension

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Djulis-Buckwheat & Placebo

    Buckwheat & Placebo

    Djulis-Buckwheat & Buckwheat

    Arm Description

    Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks

    Ingest Buckwheat or placebo drink 100ml/day for 8 weeks

    Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks

    Outcomes

    Primary Outcome Measures

    Change of blood pressure

    Secondary Outcome Measures

    Full Information

    First Posted
    June 14, 2016
    Last Updated
    July 6, 2016
    Sponsor
    Taipei Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02825901
    Brief Title
    Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
    Official Title
    Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University Hospital

    4. Oversight

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prehypertension, Hypertension Stage 1

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Djulis-Buckwheat & Placebo
    Arm Type
    Active Comparator
    Arm Description
    Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks
    Arm Title
    Buckwheat & Placebo
    Arm Type
    Active Comparator
    Arm Description
    Ingest Buckwheat or placebo drink 100ml/day for 8 weeks
    Arm Title
    Djulis-Buckwheat & Buckwheat
    Arm Type
    Experimental
    Arm Description
    Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Djulis-Buckwheat
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Buckwheat
    Primary Outcome Measure Information:
    Title
    Change of blood pressure
    Time Frame
    Baseline, 1, 2, 4, 6, and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shih Chun-Ming, PhD
    Phone
    886-2-27372181
    Ext
    8603
    Email
    cmshih53@tmu.edu.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

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