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The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population

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ClinicalTrials.gov Identifier: NCT03454347
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Sanford Research
Information provided by (Responsible Party):
Lee Weidauer, South Dakota State University

Tracking Information
First Submitted Date  ICMJE February 22, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date March 5, 2018
Actual Study Start Date  ICMJE February 22, 2018
Estimated Primary Completion Date January 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
Muscle Mass [ Time Frame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension ]
Whole body muscle mass (kg) will be measured using DXA while muscle cross-sectional area of the lower leg will be measured via pQCT
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
Muscle strength [ Time Frame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension ]
Torque production (NM) will be measured using isokinetic testing with a Biodex System 4 Ergometer. The protocol will include maximal quadricep extension and hamstring flexion performed at 60, 180, and 300 degrees per second
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 2, 2018)
  • Volumetric bone mineral density [ Time Frame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension ]
    Volumetric bone mineral density (mg/cm^2) at the 66% slice of the tibia will be measured using pQCT
  • Bone Cross-Sectional Area [ Time Frame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension ]
    Total bone cross sectional area (cm^2) at the 66% slice of the tibia will be measured
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
Official Title  ICMJE The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
Brief Summary

Following orthopedic surgery and/or injury, a significant loss of muscle mass is generally observed. While this loss of muscle mass appears to be the norm, it causes significant problems in both the athletic and general population. Athletes struggle to regain their performance because of the decrease in muscle mass and also have a greater potential for reinjury while they are in a depleted state. In the general population, and particularly among the elderly, this loss in muscle mass can be even more devastating because as people age, it is more difficult to regain muscle after it is lost. In elderly individuals, this loss in muscle mass can lead to significant disability, diminished quality of life along with an increased risk of falls. In addition to the muscle mass lost during the post-operative period, the strength of the muscle also decreases. This has obvious performance implications in athletes, as well as having the potential to extend recovery time. In the elderly, decreased strength may result in reduced independence and inability to perform activities of daily living. Many previous bed rest studies have reported that significant bone loss also occurs during times of decreased mechanical loading. The post-operative period generally results in decreased mechanical loading; however, some muscle loading will still occur during the rehabilitation process. The dynamic relation between muscle activity/loading and bone density changes in the post-operative state has not been fully described and requires further study.

With this knowledge of the importance of nutrition to the musculoskeletal system, applying the principles of increased protein intake through the addition of a dietary supplement to a population preparing for orthopedic surgery and subsequent muscle disuse is a logical next step. The investigators hypothesize that through the consumption of a protein-based dietary supplement three times per day (75g protein), along with educating patients on the importance of consuming foods that are high in protein, there will be an attenuation of decreases in muscle mass and strength as well as losses in bone that occur with orthopedic injury and disuse. The investigators long-term goal is to identify a nutritional protocol that can be implemented prior to and following orthopedic surgery to diminish the deleterious effects of the subsequent disuse on muscle and bone.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Disuse Atrophy
Intervention  ICMJE
  • Dietary Supplement: Profile Perform
    The dietary supplement includes 1.5 grams of fat, 19 grams of carbohydrate, and 25 grams of protein per serving. Participants in the experimental group will consume 3 servings per day.
  • Other: Lower Limb Suspension
    This group will complete two weeks of lower limb suspension.
Study Arms  ICMJE
  • Experimental: Protein Supplementation Group
    Participants in this group will complete two weeks of lower limb suspension and receive 75g/day of supplemental protein in addition to education aimed at increasing protein intake through their diet.
    Intervention: Dietary Supplement: Profile Perform
  • Active Comparator: Non-Supplemental Group
    Participants in this group will complete two weeks of lower limb suspension and will receive no supplementation or nutritional education.
    Intervention: Other: Lower Limb Suspension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 22, 2020
Estimated Primary Completion Date January 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants will be physically active males and females aged 18-25 with no history of a lower extremity injury 12 months prior to participation. Physically active will be classified as participating in physical activity for at least 3 minutes and a minimum of 3 days per week.

Exclusion Criteria:

  • Participants will be excluded if they are participating in any other research projects that could potentially affect the outcomes of this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lee Weidauer, PhD 6056884630 Lee.Weidauer@sdstate.edu
Contact: Matthew Vukovich, PhD 6056886580 Matt.Vukovich@sdstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03454347
Other Study ID Numbers  ICMJE IRB-1801014-EXP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lee Weidauer, South Dakota State University
Study Sponsor  ICMJE South Dakota State University
Collaborators  ICMJE Sanford Research
Investigators  ICMJE Not Provided
PRS Account South Dakota State University
Verification Date March 2018

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