NCT03483558

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
Last Updated

March 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

January 31, 2018

Last Update Submit

March 28, 2018

Conditions

Vegetable Signature Documentation With Metabolomic Technique

Keywords

vegetable metabolite signaturehuman serum/urinary metaboliteliquid chromatography mass spectrometry

Outcome Measures

Primary Outcomes (14)

  • 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)

Study Arms (5)

Control

EXPERIMENTAL

Participants were fed a standardized diet (without any vegetables) in this experiment.

Other: Control

Spinach

EXPERIMENTAL

Participants were fed a standardized diet with 200g spinach in this experiment.

Other: Spinach

Celery

EXPERIMENTAL

Participants were fed a standardized diet with 200g celery in this experiment.

Other: Celery

Onion

EXPERIMENTAL

Participants were fed a standardized diet with 200g onion in this experiment.

Other: Onion

Mixed Vegetables

EXPERIMENTAL

Participants were fed a standardized diet with 200g of mixed vegetables (spinach, celery, and onion) in this experiment.

Other: Mixed Vegetables

Interventions

ControlOTHER

A standardized diet without any vegetables was provided.

Control
SpinachOTHER

A standardized diet with 200g spinach was provided.

Spinach
CeleryOTHER

A standardized diet with 200g celery was provided.

Celery
OnionOTHER

A standardized diet with 200g onion was provided.

Onion
Mixed VegetablesOTHER

A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.

Mixed Vegetables

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Wen-Harn Pan, Ph.D.

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

March 30, 2018

Study Start

June 11, 2011

Primary Completion

December 31, 2012

Study Completion

May 28, 2015

Last Updated

March 30, 2018

Record last verified: 2018-01