Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection

NCT02825901 | Withdrawn

• 1 other identifier: N201604003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Prehypertension; Hypertension Stage 1

Outcome Measures

Primary Outcomes (1)

• Change of blood pressure

  Baseline, 1, 2, 4, 6, and 8 weeks

Study Arms (3)

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

Placebo DIETARY_SUPPLEMENT

Ingest placebo drink 100ml/day for 8 weeks

Buckwheat & Placebo; Djulis-Buckwheat & Placebo

Djulis-Buckwheat DIETARY_SUPPLEMENT

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

Djulis-Buckwheat & Buckwheat; Djulis-Buckwheat & Placebo

Buckwheat DIETARY_SUPPLEMENT

Ingest Buckwheat drink 100ml/day for 8 weeks

Buckwheat & Placebo; Djulis-Buckwheat & Buckwheat

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: July 7, 2016
• Study Start: March 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 22, 2023

Record last verified: 2018-03