Establish a Vegetable Signature Database From Human Metabolomics Responses

Blood Pressure Clinical Trial

Official title:

Establish a Vegetable Signature Database From Human Metabolomics Responses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01600911
• Other study ID #: EC0991003
• Status: Active, not recruiting
• Phase: N/A
• First received: May 16, 2012
• Last updated: May 17, 2012
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2012
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age :18-60 years

• Body Mass Index :18.5-30(kg/m2)

• Non-smoking,alcohol abusing,and other bad hobbies

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Human Metabolomic Responses to Plant Foods

Intervention

Other:
• Low phytochemical diet(LPD), high phytochemical diet(HPD)
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.

Locations

Country	Name	City	State
Taiwan	National Health Research institues, Taiwan	Miaoli County

Sponsors (2)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	fasting, before lunch,and every 1 hr after lunch	one day	No
Secondary	metabolomic profile of serum and urine	serum sample will be measure fasting ,before lunch,and every 1 hr after lunch;urine sample will be measure fasting ,before lunch(0hr),0-2 hr,2-4hr 4-7hr after lunch	one day	No