Vegetable Signature Documentation With Metabolomic TechniqueNCT03483558
Vegetable Signature From Human Metabolomics Responses
A study testing Spinach, Celery and Onion in people with Vegetable Signature Documentation With Metabolomic Technique, run by National Health Research Institutes, Taiwan.
Trial summary
The purpose of this study is to perform dietary intervention studies on a variety of vegetables. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vegetable Signature Documentation With Metabolomic Technique
- What is being tested?
- Spinach, Celery and Onion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2011to 28 May 2015
- 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
- BMI 18.5~30 kg/m2
- non-smoker
- non-alcoholic
Who cannot join
- Unwilling to stop taking the dietary supplements that may affect the experiment result.
- Unwilling to take the provided meal during the designated period.
- Taking hypertension or diabetes drugs.
- Diagnosed immune diseases (such as allergic diseases, autoimmune diseases, etc.), liver diseases, metabolic diseases (such as hyperthyroidism or hypothyroidism), or other not suitable for the dietary study.
- Diagnosed cancer or other severe diseases.
- Suffered from urinary tract infection or took antibiotic in the past three months
About this study
Official title: Dietary Intervention Studies on a Variety of Vegetables
The purpose of this study is to perform dietary intervention studies on a variety of vegetables.
Read the detailed description
Plant-based foods have always been an important component of a healthy diet. High intake of plant foods may not only maintain normal bodily functions through the provision of dietary fiber, vitamins, and minerals but also relieve symptoms and prevent diseases. Many studies have pointed out that high intake of plant foods may reduce the incidence of non-communicable disease. Past research investigating the effect of phytochemicals has usually been limited to single substances or single foods. However, a number of researchers have pointed out that phytonutrients and dietary components are likely to act synergistically.Health effects and mechanisms of phytonutrients in combination have not been carefully studied in population settings. The technology of metabolomics has enabled the simultaneous measurement of hundreds of small molecules in biological samples. Exploring the change of metabolites after feeding can not only help us understand the role of plant foods, but may also provide opportunities to assess plant food intake levels.
- Being tested
- Control, Spinach, Celery, Onion, Mixed Vegetables
- Keywords
- vegetable metabolite signature, human serum/urinary metabolite, liquid chromatography mass spectrometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
A standardized diet without any vegetables was provided.
SpinachOther
A standardized diet with 200g spinach was provided.
CeleryOther
A standardized diet with 200g celery was provided.
OnionOther
A standardized diet with 200g onion was provided.
Mixed VegetablesOther
A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Participants were fed a standardized diet (without any vegetables) in this experiment. Receives: Other: Control |
| Spinach | Experimental | Participants were fed a standardized diet with 200g spinach in this experiment. Receives: Other: Spinach |
| Celery | Experimental | Participants were fed a standardized diet with 200g celery in this experiment. Receives: Other: Celery |
| Onion | Experimental | Participants were fed a standardized diet with 200g onion in this experiment. Receives: Other: Onion |
| Mixed Vegetables | Experimental | Participants were fed a standardized diet with 200g of mixed vegetables (spinach, celery, and onion) in this experiment. Receives: Other: Mixed Vegetables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: Baseline (fasting state before breakfast at 7:30AM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 4 Hours (immediately before lunch at 11:30AM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 5.5 hours (after lunch at 13:00PM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 6.5 hours (after lunch at 14:00 PM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 7.5 hours (after lunch at 15:00PM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 8.5 hours (after lunch at 16:00PM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 9.5 hours (after lunch at 17:00PM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 10.5 hours (after lunch at 18:00PM)
Intensities of multiple serum metabolites
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 11.5 hours (after lunch at 19:00PM)
Intensities of multiple urinary metabolites
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: Baseline (overnight urine sample collected at 7:30AM)
Intensities of multiple urinary metabolites
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 3.5~4 hours (before lunch urine sample collected during 11:00~11:30AM)
Intensities of multiple urinary metabolites
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 4.5~6.5 hours (2-hour after lunch urine sample collected from 12:00 to 14:00PM)
Intensities of multiple urinary metabolites
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 6.5~8.5 hours (4-hour after lunch urine sample collected from 14:00 to 16:00PM)
Intensities of multiple urinary metabolites
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Measured: 8.5~11.5 hours (7-hour after lunch urine sample collected from 16:00 to 19:00PM)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start11 Jun 2011
- Primary completion31 Dec 2012
- Study completion28 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vegetable Signature Documentation With Metabolomic TechniqueStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Academia Sinica, Taiwan, Tri-Service General Hospital (TSGH), Fu Jen Catholic University
- Responsible party
- Sponsor
- Investigators
- Wen-Harn Pan, Ph.D., Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483558
- Sponsor's protocol ID
- NHRI_EC0991003
- Status last verified
- Jan 2018
- First submitted
- 31 Jan 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention Studies on a Variety of Vegetables
- ClinicalTrials.gov ID
- NCT03483558
- Acronym / sponsor ID
- NHRI_EC0991003
- Keywords
- vegetable metabolite signature, human serum/urinary metabolite, liquid chromatography mass spectrometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Academia Sinica, Taiwan, Tri-Service General Hospital (TSGH), Fu Jen Catholic University
- Study start
- 11 Jun 2011 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 28 May 2015 (actual)
- First posted
- 30 Mar 2018 (actual)
- 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 this study is to perform dietary intervention studies on a variety of vegetables.
Detailed description
Plant-based foods have always been an important component of a healthy diet. High intake of plant foods may not only maintain normal bodily functions through the provision of dietary fiber, vitamins, and minerals but also relieve symptoms and prevent diseases. Many studies have pointed out that high intake of plant foods may reduce the incidence of non-communicable disease. Past research investigating the effect of phytochemicals has usually been limited to single substances or single foods. However, a number of researchers have pointed out that phytonutrients and dietary components are likely to act synergistically.Health effects and mechanisms of phytonutrients in combination have not been carefully studied in population settings. The technology of metabolomics has enabled the simultaneous measurement of hundreds of small molecules in biological samples. Exploring the change of metabolites after feeding can not only help us understand the role of plant foods, but may also provide opportunities to assess plant food intake levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlParticipants were fed a standardized diet (without any vegetables) in this experiment. |
| Spinach | Experimental | Other: SpinachParticipants were fed a standardized diet with 200g spinach in this experiment. |
| Celery | Experimental | Other: CeleryParticipants were fed a standardized diet with 200g celery in this experiment. |
| Onion | Experimental | Other: OnionParticipants were fed a standardized diet with 200g onion in this experiment. |
| Mixed Vegetables | Experimental | Other: Mixed VegetablesParticipants were fed a standardized diet with 200g of mixed vegetables (spinach, celery, and onion) in this experiment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18.5~30 kg/m2
- non-smoker
- non-alcoholic
Key exclusion criteria (6 listed)
- Unwilling to stop taking the dietary supplements that may affect the experiment result.
- Unwilling to take the provided meal during the designated period.
- Taking hypertension or diabetes drugs.
- Diagnosed immune diseases (such as allergic diseases, autoimmune diseases, etc.), liver diseases, metabolic diseases (such as hyperthyroidism or hypothyroidism), or other not suitable for the dietary study.
- Diagnosed cancer or other severe diseases.
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 |
|---|---|---|
| ControlA standardized diet without any vegetables was provided. | Other | Control |
| SpinachA standardized diet with 200g spinach was provided. | Other | Spinach |
| CeleryA standardized diet with 200g celery was provided. | Other | Celery |
| OnionA standardized diet with 200g onion was provided. | Other | Onion |
| Mixed VegetablesA standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided. | Other | Mixed Vegetables |
Primary outcome
Intensities of multiple serum metabolites
Time frame: Baseline (fasting state before breakfast at 7:30AM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 4 Hours (immediately before lunch at 11:30AM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 5.5 hours (after lunch at 13:00PM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 6.5 hours (after lunch at 14:00 PM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 7.5 hours (after lunch at 15:00PM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 8.5 hours (after lunch at 16:00PM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 9.5 hours (after lunch at 17:00PM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 10.5 hours (after lunch at 18:00PM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple serum metabolites
Time frame: 11.5 hours (after lunch at 19:00PM)
The outcome measure consists of intensities of multiple serum metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple urinary metabolites
Time frame: Baseline (overnight urine sample collected at 7:30AM)
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple urinary metabolites
Time frame: 3.5~4 hours (before lunch urine sample collected during 11:00~11:30AM)
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple urinary metabolites
Time frame: 4.5~6.5 hours (2-hour after lunch urine sample collected from 12:00 to 14:00PM)
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple urinary metabolites
Time frame: 6.5~8.5 hours (4-hour after lunch urine sample collected from 14:00 to 16:00PM)
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Intensities of multiple urinary metabolites
Time frame: 8.5~11.5 hours (7-hour after lunch urine sample collected from 16:00 to 19:00PM)
The outcome measure consists of intensities of multiple urinary metabolites from a liquid chromatography/time-of-flight/mass spectrometry (LC/TOF/MS) experiment. Intensity means the level of response variable (a given metabolite) showing the degree of response detected by LC/TOF/MS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Individual participant dataSharing planned: Undecided
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
Questions about this trial
What is this clinical trial studying?
A study testing Spinach, Celery and Onion in people with Vegetable Signature Documentation With Metabolomic Technique, run by National Health Research Institutes, 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 6 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: finished, as of the sponsor's last update on 30 Mar 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensities of multiple serum metabolites (time frame: Baseline (fasting state before breakfast at 7:30AM)). The study lists 14 primary outcomes in all. 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 30 Mar 2018.