Clinical trial NCT03454347: The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
Official title: The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disuse Atrophy
Lead sponsor: South Dakota State University
Sponsor class: OTHER
Collaborators: name: Sanford Research
First posted: 2018-03-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Muscle Mass
timeFrame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Secondary outcomes:
measure: Muscle strength
timeFrame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Other outcomes:
measure: Volumetric bone mineral density
timeFrame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
measure: Bone Cross-Sectional Area
timeFrame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Locations:
city: Brookings
country: United States
facility: South Dakota State University
state: South Dakota
Study officials:
References: