Vegetable Signature From Human Metabolomics Responses

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: Completed
• Conditions: Vegetable Signature Documentation With Metabolomic Technique
• Intervention / Treatment: Other: Control; Other: Spinach; Other: Celery; Other: Onion; Other: Mixed 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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	8.5~11.5 hours (7-hour after lunch urine sample collected from 16:00 to 19:00PM)

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Tri-Service General Hospital; Academia Sinica, Taiwan; Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2011
• Primary Completion (ACTUAL): December 31, 2012
• Study Completion (ACTUAL): May 28, 2015

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): March 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: vegetable metabolite signature; human serum/urinary metabolite; liquid chromatography mass spectrometry
• Other Study ID 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