Human Metabolomic Responses to Plant FoodsNCT01600911
Establish a Vegetable Signature Database From Human Metabolomics Responses
A study testing Low phytochemical diet(LPD), high phytochemical diet(HPD) in people with Human Metabolomic Responses to Plant Foods and Blood Pressure, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients and non-nutrients still remains to be discovered.We design a feeding study which provides plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The goal of this study is to establish a protocol… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Metabolomic Responses to Plant Foods, Blood Pressure
- What is being tested?
- Low phytochemical diet(LPD), high phytochemical diet(HPD)
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2010to Dec 2013
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age :18-60 years
- Body Mass Index :18.5-30(kg/m2)
- Non-smoking,alcohol abusing,and other bad hobbies
Who cannot join
- With regular drug intake e.g. anti-hypertensive or antidiabetes drug or history of immune, hepatic and metabolic disease or other unsuitable disorders e.g. cancer.
- unwilling to stop regular food supplement e.g. vitamins, herb
- cannot cooperate with designed diet
- History of urinary tract infection or antibiotic use within the previous 3 month
Trial locations and contacts
1 site in 1 country.
About this study
Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients and non-nutrients still remains to be discovered.We design a feeding study which provides plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The goal of this study is to establish a protocol for documenting metabolomics response to plant foods and try to characterize plant foods in terms of their anti-hypertension potentials with metabolomic profiling information.
- Being tested
- Low phytochemical diet(LPD), high phytochemical diet(HPD)
- Keywords
- metabolomics, nutri-metabolomics, plant food, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low phytochemical diet(LPD), high phytochemical diet(HPD)Other
LPD is a basal diet which low in soy,vegetable and fruit and other plant food to approach low phytochemical. HPD is the diet which add two serving test vegetable in the lunch of LPD.
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
fasting, before lunch,and every 1 hr after lunch
Measured: one day
Secondary outcomes (1)
metabolomic profile of serum and urine
serum sample will be measure fasting ,before lunch,and every 1 hr after lunch;urine sample will be measure fasting ,before lunch(0hr),0-2 hr,2-4hr 4-7hr after lunch
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Metabolomic Responses to Plant FoodsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Wen-Harn Pan, Ph.D., Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600911
- Sponsor's protocol ID
- EC0991003
- Status last verified
- May 2012
- First submitted
- 16 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a Vegetable Signature Database From Human Metabolomics Responses
- ClinicalTrials.gov ID
- NCT01600911
- Acronym / sponsor ID
- EC0991003
- Keywords
- metabolomics, nutri-metabolomics, plant food, blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 May 2012 (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.
Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients and non-nutrients still remains to be discovered.We design a feeding study which provides plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The goal of this study is to establish a protocol for documenting metabolomics response to plant foods and try to characterize plant foods in terms of their anti-hypertension potentials with metabolomic profiling information.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age :18-60 years
- Body Mass Index :18.5-30(kg/m2)
- Non-smoking,alcohol abusing,and other bad hobbies
Key exclusion criteria (4 listed)
- With regular drug intake e.g. anti-hypertensive or antidiabetes drug or history of immune, hepatic and metabolic disease or other unsuitable disorders e.g. cancer.
- unwilling to stop regular food supplement e.g. vitamins, herb
- cannot cooperate with designed diet
- History of urinary tract infection or antibiotic use within the previous 3 month
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 |
|---|---|---|
| Low phytochemical diet(LPD), high phytochemical diet(HPD)LPD is a basal diet which low in soy,vegetable and fruit and other plant food to approach low phytochemical. HPD is the diet which add two serving test vegetable in the lunch of LPD. | Other | – |
Primary outcome
blood pressure
Time frame: one day
fasting, before lunch,and every 1 hr after lunch
1 secondary outcome
metabolomic profile of serum and urine
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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.
Wen-Harn Pan, Ph.D. principal investigator
National Health Research Institutes, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low phytochemical diet(LPD), high phytochemical diet(HPD) in people with Human Metabolomic Responses to Plant Foods and Blood Pressure, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
blood pressure (time frame: one day). 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 18 May 2012.