CancerNCT00446888
Effects of Nutritional Supplementation (Product 4808) on Acute Skeletal Muscle Protein Synthesis in Cancer Patients
A study testing Standardized Meals for Diet Stabilization, Forticare and Product 4808 in people with Cancer, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Standardized Meals for Diet Stabilization, Forticare and Product 4808
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radiographic evidence of Cancer
- Ages 40 and older
- Ability to sign Informed Consent
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Standardized Meals for Diet Stabilization, Forticare, Product 4808
- Keywords
- cancer, metastasis
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Meals for Diet StabilizationBehavioural
Subjects will eat prepared meals for 3 days prior to their study; or they will document their dietary intake over this period.
ForticareDietary supplement
400 ml of commercially-available nutritional supplement.
Product 4808Dietary supplement
Also called Product 4808.
400 ml Forticare, to which has been added extra protein and the amino acid leucine.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | these subjects will get a standard protein supplement "milkshake" during thei study. Receives: 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. Receives: Behavioral: Standardized Meals for Diet Stabilization; Dietary Supplement: Product 4808 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fractional synthetic rate of growth.
Measured: one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Robert Wolfe, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446888
- Sponsor's protocol ID
- 71303
- Status last verified
- Jun 2009
- First submitted
- 9 Mar 2007
- Last updated
- 19 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Supplementation (Product 4808) on Acute Skeletal Muscle Protein Synthesis in Cancer Patients
- ClinicalTrials.gov ID
- NCT00446888
- Acronym / sponsor ID
- 71303
- Conditions
- Cancer
- Keywords
- cancer, metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Standardized Meals for Diet Stabilization, Dietary Supplement: Forticarethese subjects will get a standard protein supplement "milkshake" during thei study. |
| 2 | Experimental | Behavioral: Standardized Meals for Diet Stabilization, Dietary Supplement: Product 4808these subjects will receive an enhanced protein supplement "milkshake" during their study. Product 4808. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- radiographic evidence of Cancer
- Ages 40 and older
- Ability to sign Informed Consent
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Meals for Diet StabilizationSubjects will eat prepared meals for 3 days prior to their study; or they will document their dietary intake over this period. | Behavioural | 1, 2 |
| Forticare400 ml of commercially-available nutritional supplement. | Dietary supplement | 1 |
| Product 4808Also: Product 4808.400 ml Forticare, to which has been added extra protein and the amino acid leucine. | Dietary supplement | 2 |
Primary outcome
Muscle fractional synthetic rate of growth.
Time frame: one day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wolfe, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Meals for Diet Stabilization, Forticare and Product 4808 in people with Cancer, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle fractional synthetic rate of growth. (time frame: one day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2009.