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WithdrawnNCT02825901Updated Nov 22, 2023

Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

An interventional study of Placebo and Djulis-Buckwheat in Prehypertension and Hypertension Stage 1, sponsored by Taipei Medical University Hospital. Withdrawn. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Taipei Medical University Hospital · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Due to company policy, the development of this product is suspended.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Prehypertension
  • Hypertension Stage 1

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03

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Systolic blood pressure 121-159 mmHg or Diastolic blood pressure 81-99 mmHg
  • Age: 30-65

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementPlacebo

    Ingest placebo drink 100ml/day for 8 weeks

  • Dietary supplementDjulis-Buckwheat

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

  • Dietary supplementBuckwheat

    Ingest Buckwheat drink 100ml/day for 8 weeks

05

What researchers measure

Primary outcomes

  1. Change of blood pressure

    Time frame: Baseline, 1, 2, 4, 6, and 8 weeks

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT02825901
Lead sponsor
Taipei Medical University Hospital
Responsible party
Sponsor
First posted
Jul 7, 2016
Start date
Mar 2019 (estimated)
Primary completion
Jan 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Nov 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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