Effects of PS-IPC Supplementation on Muscle Mass and Functional Outcomes in Older Adults

Sarcopenia Clinical Trial

— PS-IPC  

Official title:

Effects of Pro-Stat Immuno-Protein Complex (PS-IPC) Supplementation on Muscle Mass and Function, Inflammatory Markers, and Immune Function in Older Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00926250
• Other study ID #: 109167
• Status: Terminated
• Phase: N/A
• First received: June 22, 2009
• Last updated: January 17, 2012
• Start date: June 2009
• Est. completion date: January 2012

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immune Senescence
• Sarcopenia

Intervention

Dietary Supplement:
• Oral PS-IPC supplement
Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention. The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.
• Placebo supplement
Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention. The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

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