ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 616 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Disuse Atrophy Dietary Supplement: Profile Perform Other: Lower Limb Suspension Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : January 12, 2019
Estimated Study Completion Date : February 22, 2020

Arm Intervention/treatment
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.
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.

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.
Other: Lower Limb Suspension
This group will complete two weeks of lower limb suspension.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454347


Contacts
Contact: Lee Weidauer, PhD 6056884630 Lee.Weidauer@sdstate.edu
Contact: Matthew Vukovich, PhD 6056886580 Matt.Vukovich@sdstate.edu

Locations
United States, South Dakota
South Dakota State University Recruiting
Brookings, South Dakota, United States, 57007
Contact: Lee Weidauer, PhD    605-688-4630    Lee.Weidauer@sdstate.edu   
Contact: Matt Vukovich, PhD    6056886580    Matt.Vukovich@sdstate.edu   
Sponsors and Collaborators
South Dakota State University
Sanford Research

Responsible Party: Lee Weidauer, Assistant Professor, South Dakota State University
ClinicalTrials.gov Identifier: NCT03454347     History of Changes
Other Study ID Numbers: IRB-1801014-EXP
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Muscular Diseases
Atrophy
Muscular Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Diseases
Neuromuscular Diseases