Vegetable Signature From Human Metabolomics Responses

Vegetable Signature Documentation With Metabolomic Technique Clinical Trial

Official title:

Dietary Intervention Studies on a Variety of Vegetables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483558
• Other study ID #: NHRI_EC0991003
• Status: Completed
• Phase: N/A
• First received: January 31, 2018
• Last updated: March 28, 2018
• Start date: June 11, 2011
• Est. completion date: May 28, 2015

Study information

• Verified date: January 2018
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 28, 2015
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Vegetable Signature Documentation With Metabolomic Technique

Intervention

Other:
• Control
A standardized diet without any vegetables was provided.
• Spinach
A standardized diet with 200g spinach was provided.
• Celery
A standardized diet with 200g celery was provided.
• Onion
A standardized diet with 200g onion was provided.
• Mixed Vegetables
A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Academia Sinica, Taiwan, Fu Jen Catholic University, Tri-Service General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)