Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

Not Applicable

Withdrawn

• Conditions: Hypertension Stage 1; Prehypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Buckwheat; Dietary Supplement: Djulis-Buckwheat

• Registration Number: NCT02825901
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-07
• Status Verified: 2018-03
• Study Start: 2019-03
• Primary Completion: 2020-01
• Study Completion: 2020-12
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Djulis-Buckwheat & Buckwheat	Buckwheat	Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks
Djulis-Buckwheat & Placebo	Djulis-Buckwheat	Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks
Djulis-Buckwheat & Placebo	Placebo	Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks
Buckwheat & Placebo	Placebo	Ingest Buckwheat or placebo drink 100ml/day for 8 weeks
Djulis-Buckwheat & Buckwheat	Djulis-Buckwheat	Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks
Buckwheat & Placebo	Buckwheat	Ingest Buckwheat or placebo drink 100ml/day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change of blood pressure	Baseline, 1, 2, 4, 6, and 8 weeks