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Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

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ClinicalTrials.gov Identifier: NCT02825901
Recruitment Status : Unknown
Verified June 2016 by Taipei Medical University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Hospital

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date July 7, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
Change of blood pressure [ Time Frame: Baseline, 1, 2, 4, 6, and 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
Official Title  ICMJE Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Prehypertension
  • Hypertension Stage 1
Intervention  ICMJE
  • Dietary Supplement: Placebo
  • Dietary Supplement: Djulis-Buckwheat
  • Dietary Supplement: Buckwheat
Study Arms  ICMJE
  • Active Comparator: Djulis-Buckwheat & Placebo
    Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks
    Interventions:
    • Dietary Supplement: Placebo
    • Dietary Supplement: Djulis-Buckwheat
  • Active Comparator: Buckwheat & Placebo
    Ingest Buckwheat or placebo drink 100ml/day for 8 weeks
    Interventions:
    • Dietary Supplement: Placebo
    • Dietary Supplement: Buckwheat
  • Experimental: Djulis-Buckwheat & Buckwheat
    Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks
    Interventions:
    • Dietary Supplement: Djulis-Buckwheat
    • Dietary Supplement: Buckwheat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 6, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825901
Other Study ID Numbers  ICMJE N201604003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taipei Medical University Hospital
Study Sponsor  ICMJE Taipei Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taipei Medical University Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP