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

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.

Study Overview

• Status: Completed
• Conditions: Disuse Atrophy
• Intervention / Treatment: Dietary supplement: Profile Perform; Other: Lower Limb Suspension

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Brookings, South Dakota, United States, 57007
      • South Dakota State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Mass	Whole body muscle mass (kg) will be measured using DXA while muscle cross-sectional area of the lower leg will be measured via pQCT	Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	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	Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric bone mineral density	Volumetric bone mineral density (mg/cm^2) at the 66% slice of the tibia will be measured using pQCT	Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Bone Cross-Sectional Area	Total bone cross sectional area (cm^2) at the 66% slice of the tibia will be measured	Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension

Collaborators and Investigators

• Sponsor: South Dakota State University
• Collaborators: Sanford Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2018
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): May 10, 2022

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Muscular Disorders, Atrophic
• Other Study ID Numbers: IRB-1801014-EXP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No