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Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

NCT ID: NCT02825901

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Prehypertension Hypertension Stage 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Djulis-Buckwheat & Placebo

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Ingest placebo drink 100ml/day for 8 weeks

Djulis-Buckwheat

Intervention Type DIETARY_SUPPLEMENT

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

Buckwheat & Placebo

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Ingest placebo drink 100ml/day for 8 weeks

Buckwheat

Intervention Type DIETARY_SUPPLEMENT

Ingest Buckwheat drink 100ml/day for 8 weeks

Djulis-Buckwheat & Buckwheat

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

Group Type EXPERIMENTAL

Djulis-Buckwheat

Intervention Type DIETARY_SUPPLEMENT

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

Buckwheat

Intervention Type DIETARY_SUPPLEMENT

Ingest Buckwheat drink 100ml/day for 8 weeks

Interventions

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Placebo

Ingest placebo drink 100ml/day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Djulis-Buckwheat

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

Intervention Type DIETARY_SUPPLEMENT

Buckwheat

Ingest Buckwheat drink 100ml/day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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N201604003

Identifier Type: -

Identifier Source: org_study_id