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

NCT ID: NCT03454347

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2022-05-10

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.

Conditions

Disuse Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Profile Perform

Intervention Type: DIETARY_SUPPLEMENT

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.

Non-Supplemental Group

Participants in this group will complete two weeks of lower limb suspension and will receive no supplementation or nutritional education.

Group Type: ACTIVE_COMPARATOR

Lower Limb Suspension

Intervention Type: OTHER

This group will complete two weeks of lower limb suspension.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Lower Limb Suspension

This group will complete two weeks of lower limb suspension.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanford Research

OTHER

Sponsor Role: collaborator

South Dakota State University

OTHER

Sponsor Role: lead

Responsible Party

Lee Weidauer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South Dakota State University

Brookings, South Dakota, United States

Countries

United States

Other Identifiers

IRB-1801014-EXP

Identifier Type: -

Identifier Source: org_study_id