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

NCT ID: NCT00926250

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-01-31

Brief 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.

Conditions

Immune Senescence; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PS-IPC supplementation

Group Type: EXPERIMENTAL

Oral PS-IPC supplement

Intervention Type: DIETARY_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 supplementation

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arny A Ferrando, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

109167

Identifier Type: -

Identifier Source: org_study_id