Sarcopenia Clinical Trial
— PS-IPCOfficial title:
Effects of Pro-Stat Immuno-Protein Complex (PS-IPC) Supplementation on Muscle Mass and Function, Inflammatory Markers, and Immune Function in Older Adults
Verified date | January 2012 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Sarcopenia, the age-associated loss of skeletal muscle mass and strength, is a frequent
precursor to functional impairment, disability, falls, and loss of independence in the
elderly. The prevalence of sarcopenia is high, with ≥ 45% of the U.S. population aged 60
years or older sarcopenic. Some possible causative factors include a decline in muscle
protein synthesis, inactivity, hormonal changes, pro-inflammatory conditions, and reactive
oxygen species within the muscle mitochondria, which may all be exacerbated by inadequate
nutritional intake. Since dietary protein is targeted to muscle and muscle mass represents
the largest tissue in the body, protein nutrition plays a significant role in muscle
metabolism.
SPECIFIC AIMS The specific aim of this proposed study is to determine the effect of PS-IPC
supplementation on muscle mass, muscle strength, muscle quality, and inflammatory / immune
markers in healthy older adults. Subjects scoring 4 - 10 on the Short-Physical Performance
Battery and aged 60-85 years will consume PS-IPC supplements or placebo three times daily
for 12 weeks.
HYPOTHESES
1. Subjects consuming PS-IPC will have a greater increase in muscle mass and muscle
strength compared to a control group consuming a placebo supplement.
2. Subjects consuming PS-IPC will demonstrate a greater increase in the fractional rate of
muscle protein synthesis compared with a placebo control group.
3. Subjects receiving PS-IPC will have a reduction in plasma concentrations of various
inflammatory markers of immune function, compared to subjects consuming the placebo.
Status | Terminated |
Enrollment | 18 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Years to 85 Years |
Eligibility |
Inclusion Criteria: - BMI of less than or equal to 35 kg/m2, be weight stable (+/- 5 kg) over the previous 4 months (via oral report), report the absence of alcohol or drug abuse, require minimal help in performing activities of daily living, and have a Short Physical Performance Battery score of 4 - 10. Exclusion Criteria: - Subjects with acute or chronic disease or who may be using drugs that might interfere with skeletal muscle metabolism / function or immune function will be excluded from participation. Other exclusion criteria include cognitive deficits identified by a Mini-Mental State Examination score < 24, mobility impairment requiring a wheelchair, infections, endocrine diseases (e.g., diabetes or untreated thyroid dysfunction), active inflammatory conditions, autoimmune disorders, renal dysfunction, anemia (hemoglobin < 11.5 g/dL), cardiac problems in preceding 3 months or congestive heart failure, chronic obstructive lung disease, neoplasia other than of the skin during the preceding 5 years, influenza vaccine within last 3 weeks or other vaccines within last 6 weeks, known systemic reaction to any immune function test antigen, and use of the following drugs: immunosuppressants, antianginal agents, antiarrhythmics, antibiotics within last 2 weeks, and oral steroids. Other conditions may be used as inclusion / exclusion criteria at the discretion of the study physician to ensure the safe participation of potential study subjects. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle protein synthesis | 14-16 months | No | |
Secondary | Body composition | 14-16 months | No | |
Secondary | Skeletal muscle strength and function | 14-16 months | No | |
Secondary | Immune function | 14-16 months | No | |
Secondary | Physical activity level | 14-16 months | No | |
Secondary | Self-perceived quality of life | 14-16 months | No |
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