Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascu... | NCT02825901

Studies
Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

NCT02825901

Sponsor

Taipei Medical University Hospital

Status

Withdrawn

Last Update Posted

Nov 22, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Prehypertension
Hypertension Stage 1

Interventions

Placebo
Djulis-Buckwheat
Buckwheat

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to company policy, the development of this product is suspended.

Expanded Access Info

Start Date

Mar 2019Estimated

Primary Completion Date

Jan 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Jul 6, 2016

First Posted Date

Jul 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Djulis-Buckwheat & Placebo	Active Comparator	Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks	Dietary Supplement: Placebo Dietary Supplement: Djulis-Buckwheat
Buckwheat & Placebo	Active Comparator	Ingest Buckwheat or placebo drink 100ml/day for 8 weeks	Dietary Supplement: Placebo Dietary Supplement: Buckwheat
Djulis-Buckwheat & Buckwheat	Experimental	Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks	Dietary Supplement: Djulis-Buckwheat Dietary Supplement: Buckwheat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Ingest placebo drink 100ml/day for 8 weeks	Buckwheat & Placebo Djulis-Buckwheat & Placebo

Measure	Description	Time Frame
Change of blood pressure		Baseline, 1, 2, 4, 6, and 8 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058246	Prehypertension
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided