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NCT00926250 · ClinicalTrials.gov registry record · NA
Effects of PS-IPC Supplementation on Muscle Mass and Functional Outcomes in Older Adults
A NA study, sponsored by University of Arkansas.
- Terminated
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT00926250 is a NA study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 18 participants.
The verdict
NCT00926250, a NA study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Placebo supplement
- DIETARY_SUPPLEMENT Oral PS-IPC supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00926250
The ClinicalTrials.gov registry entry for NCT00926250 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo supplement is the first listed.
NCT00926250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00926250 about?
NCT00926250 is a clinical study titled "Effects of PS-IPC Supplementation on Muscle Mass and Functional Outcomes 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 poss...
What is the current status of trial NCT00926250?
This trial is currently terminated. It is a NA study. The enrollment target is 18 participants. The study started on 2009-06. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00926250?
The interventions under investigation include: Placebo supplement (DIETARY_SUPPLEMENT), Oral PS-IPC supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00926250?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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