Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Sponsor changed their study product and halted study.)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00926250
First received: June 22, 2009
Last updated: January 17, 2012
Last verified: January 2012

June 22, 2009
January 17, 2012
June 2009
January 2012   (final data collection date for primary outcome measure)
Muscle protein synthesis [ Time Frame: 14-16 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00926250 on ClinicalTrials.gov Archive Site
  • Body composition [ Time Frame: 14-16 months ] [ Designated as safety issue: No ]
  • Skeletal muscle strength and function [ Time Frame: 14-16 months ] [ Designated as safety issue: No ]
  • Immune function [ Time Frame: 14-16 months ] [ Designated as safety issue: No ]
  • Physical activity level [ Time Frame: 14-16 months ] [ Designated as safety issue: No ]
  • Self-perceived quality of life [ Time Frame: 14-16 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of PS-IPC Supplementation on Muscle Mass and Functional Outcomes in Older Adults
Effects of Pro-Stat Immuno-Protein Complex (PS-IPC) Supplementation on Muscle Mass and Function, Inflammatory Markers, and Immune Function in Older Adults

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Immune Senescence
  • Sarcopenia
  • 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.
  • Dietary Supplement: 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.
  • Experimental: PS-IPC supplementation
    Intervention: Dietary Supplement: Oral PS-IPC supplement
  • Placebo Comparator: Placebo supplementation
    Intervention: Dietary Supplement: Placebo supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
60 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00926250
109167
No
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Arny A Ferrando, PhD University of Arkansas
University of Arkansas
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP