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Trial record 29 of 428 for:    Taipei Medical University Hospital

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

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).


Condition or disease Intervention/treatment Phase
Prehypertension Hypertension Stage 1 Dietary Supplement: Placebo Dietary Supplement: Djulis-Buckwheat Dietary Supplement: Buckwheat Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
Study Start Date : July 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Active Comparator: Djulis-Buckwheat & Placebo
Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks
Dietary Supplement: Placebo
Dietary Supplement: Djulis-Buckwheat
Active Comparator: Buckwheat & Placebo
Ingest Buckwheat or placebo drink 100ml/day for 8 weeks
Dietary Supplement: Placebo
Dietary Supplement: Buckwheat
Experimental: Djulis-Buckwheat & Buckwheat
Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks
Dietary Supplement: Djulis-Buckwheat
Dietary Supplement: Buckwheat



Primary Outcome Measures :
  1. Change of blood pressure [ Time Frame: Baseline, 1, 2, 4, 6, and 8 weeks ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825901


Contacts
Contact: Shih Chun-Ming, PhD 886-2-27372181 ext 8603 cmshih53@tmu.edu.tw

Sponsors and Collaborators
Taipei Medical University Hospital

Responsible Party: Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT02825901     History of Changes
Other Study ID Numbers: N201604003
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases