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

Completed · Not applicable

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00446888

Run by

University of Arkansas

People needed

35

Starts

2007-01-01

Expected to finish

2009-03-01

Last updated by the study team

2009-06-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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