NCT01600911

Brief Summary

Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients and non-nutrients still remains to be discovered.We design a feeding study which provides plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The goal of this study is to establish a protocol for documenting metabolomics response to plant foods and try to characterize plant foods in terms of their anti-hypertension potentials with metabolomic profiling information.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

May 16, 2012

Last Update Submit

May 17, 2012

Conditions

Keywords

metabolomicsnutri-metabolomicsplant foodblood pressure

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    fasting, before lunch,and every 1 hr after lunch

    one day

Secondary Outcomes (1)

  • metabolomic profile of serum and urine

    one day

Interventions

LPD is a basal diet which low in soy,vegetable and fruit and other plant food to approach low phytochemical. HPD is the diet which add two serving test vegetable in the lunch of LPD.

Eligibility Criteria

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

You may qualify if:

  • Age :18-60 years
  • Body Mass Index :18.5-30(kg/m2)
  • Non-smoking,alcohol abusing,and other bad hobbies

You may not qualify if:

  • With regular drug intake e.g. anti-hypertensive or antidiabetes drug or history of immune, hepatic and metabolic disease or other unsuitable disorders e.g. cancer.
  • unwilling to stop regular food supplement e.g. vitamins, herb
  • cannot cooperate with designed diet
  • History of urinary tract infection or antibiotic use within the previous 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Research institues, Taiwan

Miaoli County, Taiwan

Location

Study Officials

  • Wen-Harn Pan, Ph.D.

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 17, 2012

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations