Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients

NCT ID: NCT00950976

Last Updated: 2012-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-08-31

Brief Summary

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To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.

Detailed Description

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Conditions

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Nutritional Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Citrulline

Group Type EXPERIMENTAL

citrulline

Intervention Type OTHER

TID for 5 days

lemonade

Equal volume and flavor to citrulline.

Group Type PLACEBO_COMPARATOR

Lemonade

Intervention Type OTHER

TID for 5 days

Interventions

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citrulline

TID for 5 days

Intervention Type OTHER

Lemonade

TID for 5 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adults, male \& female, non-pregnant
* BMI 18.5-29.9

Exclusion Criteria

* cancer
* HIV positive
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan B. Ochoa, MD Prof.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ACSC-CIT-04-06-US

Identifier Type: -

Identifier Source: org_study_id

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