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

NCT00446888 | Completed

• 1 other identifier: 71303
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

cancer; metastasis

Outcome Measures

Primary Outcomes (1)

• Muscle fractional synthetic rate of growth.

  one day.

Study Arms (2)

1

ACTIVE COMPARATOR

these subjects will get a standard protein supplement "milkshake" during thei study.

Behavioral: Standardized Meals for Diet Stabilization; Dietary Supplement: Forticare

2

EXPERIMENTAL

these subjects will receive an enhanced protein supplement "milkshake" during their study. Product 4808.

Behavioral: Standardized Meals for Diet Stabilization; Dietary Supplement: Product 4808

Interventions

Standardized Meals for Diet Stabilization BEHAVIORAL

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

1; 2

Forticare DIETARY_SUPPLEMENT

400 ml of commercially-available nutritional supplement.

1

Product 4808 DIETARY_SUPPLEMENT

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

Also known as: Product 4808.

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Wolfe, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 13, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 19, 2009

Record last verified: 2009-06

Locations

US (1)