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

40 Years
Not Enrolling

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Trial Information

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

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

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Outcome Measure:

Muscle fractional synthetic rate of growth.

Outcome Time Frame:

one day.

Safety Issue:


Principal Investigator

Robert Wolfe, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

March 2009

Related Keywords:

  • Cancer
  • cancer
  • metastasis



University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205