Vegetable Signature From Human Metabolomics Responses

• ClinicalTrials.gov Identifier: NCT03483558
• Recruitment Status: Completed
• First Posted: March 30, 2018
• Last Update Posted: March 30, 2018
• Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Academia Sinica, Taiwan; Tri-Service General Hospital; Fu Jen Catholic University
• Information provided by (Responsible Party): National Health Research Institutes, Taiwan

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Vegetable Signature Documentation With Metabolomic Technique	Other: Control; Other: Spinach; Other: Celery; Other: Onion; Other: Mixed Vegetables	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Dietary Intervention Studies on a Variety of Vegetables
• Actual Study Start Date: June 11, 2011
• Actual Primary Completion Date: December 31, 2012
• Actual Study Completion Date: May 28, 2015

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

National Health Research Institutes, Taiwan

Academia Sinica, Taiwan

Tri-Service General Hospital

Fu Jen Catholic University

Investigators

• Principal Investigator: Wen-Harn Pan, Ph.D.; National Health Research Institutes, Taiwan

More Information

• Responsible Party: National Health Research Institutes, Taiwan
• ClinicalTrials.gov Identifier: NCT03483558
• Other Study ID Numbers: NHRI_EC0991003
• First Posted: March 30, 2018
• Last Update Posted: March 30, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Health Research Institutes, Taiwan:

vegetable metabolite signature; human serum/urinary metabolite; liquid chromatography mass spectrometry