The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
|ClinicalTrials.gov Identifier: NCT03454347|
Recruitment Status : Unknown
Verified March 2018 by Lee Weidauer, South Dakota State University.
Recruitment status was: Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454347
|Contact: Lee Weidauer, PhD||6056884630||Lee.Weidauer@sdstate.edu|
|Contact: Matthew Vukovich, PhD||6056886580||Matt.Vukovich@sdstate.edu|