Vegetable Signature From Human Metabolomics Responses

March 28, 2018 updated by: National Health Research Institutes, Taiwan

Dietary Intervention Studies on a Variety of Vegetables

The purpose of this study is to perform dietary intervention studies on a variety of vegetables.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 18.5~30 kg/m2
  • non-smoker
  • non-alcoholic

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Control
Participants were fed a standardized diet (without any vegetables) in this experiment.
Other: Control
A standardized diet without any vegetables was provided.
EXPERIMENTAL: Spinach
Participants were fed a standardized diet with 200g spinach in this experiment.
Other: Spinach
A standardized diet with 200g spinach was provided.
EXPERIMENTAL: Celery
Participants were fed a standardized diet with 200g celery in this experiment.
Other: Celery
A standardized diet with 200g celery was provided.
EXPERIMENTAL: Onion
Participants were fed a standardized diet with 200g onion in this experiment.
Other: Onion
A standardized diet with 200g onion was provided.
EXPERIMENTAL: Mixed Vegetables
Participants were fed a standardized diet with 200g of mixed vegetables (spinach, celery, and onion) in this experiment.
Other: Mixed Vegetables
A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (fasting state before breakfast at 7:30AM)
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.
4 Hours (immediately before lunch at 11:30AM)
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.
5.5 hours (after lunch at 13:00PM)
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.
6.5 hours (after lunch at 14:00 PM)
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.
7.5 hours (after lunch at 15:00PM)
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.
8.5 hours (after lunch at 16:00PM)
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.
9.5 hours (after lunch at 17:00PM)
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.
10.5 hours (after lunch at 18:00PM)
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.
11.5 hours (after lunch at 19:00PM)
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.
Baseline (overnight urine sample collected at 7:30AM)
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.
3.5~4 hours (before lunch urine sample collected during 11:00~11:30AM)
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.
4.5~6.5 hours (2-hour after lunch urine sample collected from 12:00 to 14:00PM)
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.
6.5~8.5 hours (4-hour after lunch urine sample collected from 14:00 to 16:00PM)
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.
8.5~11.5 hours (7-hour after lunch urine sample collected from 16:00 to 19:00PM)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Health Research Institutes, Taiwan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tri-Service General Hospital
Academia Sinica, Taiwan
Fu Jen Catholic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NHRI_EC0991003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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