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

June 17, 2009 updated by: University of Arkansas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Muscle protein is generally diminished in cancer patients, with an effect on outcome. Research has shown that recurrence in treated patients is directly related to the extent of muscle loss. The effects of nutritional supplements; however, is still controversial. Anorexia due to metabolic changes in cancer patients can lead to reduced food intake and supplementation orally has often failed to show weight gain in these patients. These observations have led to the conclusion that even though food intake should be increased in order to gain lean body mass, this is difficult to achieve unless specific metabolic abnormalities are targeted.

This study is a comparison of two supplements on muscle protein synthesis. Approximately 40 patients with radiographic evidence of cancer, ages 40 and older will be enrolled.

Participation will require a screening procedure, including a history of medical problems and a physical exam, which may include blood testing for HIV or hepatitis as well as possibly for various basic diagnostic parameters. There may also be a urine-based drug screen or pregnancy test (if female). Participants should be in general good health and not have a variety of exclusion criteria.

There will be three days of diet stabilization, during which all meals will come from the Reynolds Institute of Aging. If subjects cannot comply with the diet, dietary recording will be substituted. Following these three days, there will be one day of main study activities. There will be catheters placed in both arms and blood samples will be taken from one of these. Stable amino acid isotopes will be infused into the bloodstream through the other. There will be three muscle biopsies taken from the thigh muscle throughout the day. Two doses of a nutritional supplements will be consumed 20 minutes apart during the main study day.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • radiographic evidence of Cancer
  • Ages 40 and older
  • Ability to sign Informed Consent

Exclusion Criteria:

  • Patient received anti-cancer therapy or surgery less than 4 weeks prior to the experiment
  • Body weight loss of more than 10% in past three months
  • Body Mass Index less than 20kg/m2 or greater than 30 kg/m2
  • Any documented autoimmune disease
  • Peripheral vascular disease
  • Hgb less than 9.0g/dL
  • PT with INR greater than 1.5
  • PTT greater than 40 seconds
  • Platelet count less than 100,000
  • Uncontrolled hypertension
  • Currently using insulin to control high blood sugar
  • Untreated metabolic diseases including liver or renal disease
  • Currently in muscle strengthening program
  • Use of supplements enriched with branched-chain amino acids
  • History of hypo- or hyper-coagulation disorders, including patients taking Coumadin or history of deep venous thrombosis or pulmonary embolism at any point in their lifetime
  • Currently taking aspirin and cannot stop for 7 days
  • Presence of acute illness or metabolically unstable chronic illness
  • Unstable heart disease requiring therapy or recent myocardial infarction (less than 1 year)
  • Current alcohol or drug abuse
  • Pregnancy or lactation (pre-menopausal women)
  • Allergy/intolerance to any of the ingredients of the study products
  • Any other condition deemed by the Principal Investigator and the study physician as exclusion or that interferes with proper study conduct or safety of the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
these subjects will get a standard protein supplement "milkshake" during thei study.
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.
Experimental: 2
these subjects will receive an enhanced protein supplement "milkshake" during their study. Product 4808.
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: Product 4808
400 ml Forticare, to which has been added extra protein and the amino acid leucine.
Other Names:
  • Product 4808.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle fractional synthetic rate of growth.
Time Frame: one day.
one day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Robert Wolfe, PhD, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 9, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

June 19, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 71303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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