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Effects of Nutritional Supplementation (Product 4808) on Acute Skeletal Muscle Protein Synthesis in Cancer Patients

NCT00446888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-06-19

No results posted yet for this study

Summary

The purpose of the study is to compare two different nutritional supplements with respect to their effect on building muscle, and to determine the factors that control the rate at which muscle tissue can be produced in subjects with cancer. After three days of receiving all meals from the Reynolds Institute on Aging in order to stabilize their diet, subjects will then return to the Institute to perform a single day study, where they will be given one of two supplements to drink. Blood will be taken from a catheter placed in one of their arms and three muscle biopsy samples will be taken from a leg. Subjects will have x-ray evidence of cancer and be 40 years of age or older in order to participate. It is the hypothesis that a nutritional supplement with a high amount of protein and containing leucine will target the metabolism problems in cancer patients.

Conditions

Interventions

BEHAVIORAL

Standardized Meals for Diet Stabilization

Subjects will eat prepared meals for 3 days prior to their study; or they will document their dietary intake over this period.

DIETARY_SUPPLEMENT

Forticare

400 ml of commercially-available nutritional supplement.

DIETARY_SUPPLEMENT

Product 4808

400 ml Forticare, to which has been added extra protein and the amino acid leucine.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Robert Wolfe, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446888 on ClinicalTrials.gov