PrehypertensionNCT02825901
Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
A study testing Djulis-Buckwheat and Buckwheat in people with Prehypertension and Hypertension Stage 1, run by Taipei Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Prehypertension, Hypertension Stage 1
- What is being tested?
- Djulis-Buckwheat and Buckwheat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure 121-159 mmHg or Diastolic blood pressure 81-99 mmHg
- Age: 30-65
Who cannot join
- 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
About this study
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
- Being tested
- Placebo, Djulis-Buckwheat, Buckwheat
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Ingest placebo drink 100ml/day for 8 weeks
Djulis-BuckwheatDietary supplement
Ingest Djulis-Buckwheat drink 100ml/day for 8 weeks
BuckwheatDietary supplement
Ingest Buckwheat drink 100ml/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Djulis-Buckwheat & Placebo | Active comparator | Ingest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks Receives: Dietary Supplement: Placebo; Dietary Supplement: Djulis-Buckwheat |
| Buckwheat & Placebo | Active comparator | Ingest Buckwheat or placebo drink 100ml/day for 8 weeks Receives: Dietary Supplement: Placebo; Dietary Supplement: Buckwheat |
| Djulis-Buckwheat & Buckwheat | Experimental | Ingest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks Receives: Dietary Supplement: Djulis-Buckwheat; Dietary Supplement: Buckwheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood pressure
Measured: Baseline, 1, 2, 4, 6, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMar 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Due to company policy, the development of this product is suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825901
- Sponsor's protocol ID
- N201604003
- Status last verified
- Mar 2018
- First submitted
- 14 Jun 2016
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
- ClinicalTrials.gov ID
- NCT02825901
- Acronym / sponsor ID
- N201604003
- Conditions
- Prehypertension, Hypertension Stage 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to company policy, the development of this product is suspended.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Djulis-Buckwheat & Placebo | Active comparator | Dietary Supplement: Placebo, Dietary Supplement: Djulis-BuckwheatIngest Djulis-Buckwheat or placebo drink 100ml/day for 8 weeks |
| Buckwheat & Placebo | Active comparator | Dietary Supplement: Placebo, Dietary Supplement: BuckwheatIngest Buckwheat or placebo drink 100ml/day for 8 weeks |
| Djulis-Buckwheat & Buckwheat | Experimental | Dietary Supplement: Djulis-Buckwheat, Dietary Supplement: BuckwheatIngest Djulis-Buckwheat or Buckwheat drink 100ml/day for 8 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systolic blood pressure 121-159 mmHg or Diastolic blood pressure 81-99 mmHg
- Age: 30-65
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboIngest placebo drink 100ml/day for 8 weeks | Dietary supplement | Buckwheat & Placebo, Djulis-Buckwheat & Placebo |
| Djulis-BuckwheatIngest Djulis-Buckwheat drink 100ml/day for 8 weeks | Dietary supplement | Djulis-Buckwheat & Buckwheat, Djulis-Buckwheat & Placebo |
| BuckwheatIngest Buckwheat drink 100ml/day for 8 weeks | Dietary supplement | Buckwheat & Placebo, Djulis-Buckwheat & Buckwheat |
Primary outcome
Change of blood pressure
Time frame: Baseline, 1, 2, 4, 6, and 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Djulis-Buckwheat and Buckwheat in people with Prehypertension and Hypertension Stage 1, run by Taipei Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood pressure (time frame: Baseline, 1, 2, 4, 6, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.