Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

Taipei Medical University

Status: Withdrawn

Conditions: Prehypertension; Hypertension Stage 1

Treatments: Dietary Supplement: Djulis-Buckwheat; Dietary Supplement: Buckwheat; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02825901

N201604003

Details and patient eligibility

About

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).

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Djulis-Buckwheat & Placebo

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Djulis-Buckwheat

Dietary Supplement: Placebo

Buckwheat & Placebo

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Buckwheat

Dietary Supplement: Placebo

Djulis-Buckwheat & Buckwheat

Experimental group

Description:

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

Treatment:

Dietary Supplement: Djulis-Buckwheat

Dietary Supplement: Buckwheat