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

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00446888
First received: March 9, 2007
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Standardized Meals for Diet Stabilization
Dietary Supplement: Forticare
Dietary Supplement: Product 4808

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Effects of Nutritional Supplementation (Product 4808) on Acute Skeletal Muscle Protein Synthesis in Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Muscle fractional synthetic rate of growth. [ Time Frame: one day. ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Product 4808.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446888

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Robert Wolfe, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: Robert R. Wolfe, PhD, UAMS
ClinicalTrials.gov Identifier: NCT00446888     History of Changes
Other Study ID Numbers: 71303
Study First Received: March 9, 2007
Last Updated: June 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
cancer
metastasis

ClinicalTrials.gov processed this record on July 20, 2014