The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
Primary Purpose
Disuse Atrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Profile Perform
Lower Limb Suspension
Sponsored by
About this trial
This is an interventional treatment trial for Disuse Atrophy
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.
Sites / Locations
- South Dakota State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Protein Supplementation Group
Non-Supplemental Group
Arm Description
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.
Participants in this group will complete two weeks of lower limb suspension and will receive no supplementation or nutritional education.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03454347
First Posted
February 22, 2018
Last Updated
February 7, 2023
Sponsor
South Dakota State University
Collaborators
Sanford Research
1. Study Identification
Unique Protocol Identification Number
NCT03454347
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Dakota State University
Collaborators
Sanford Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disuse Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein Supplementation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Supplemental Group
Arm Type
Active Comparator
Arm Description
Participants in this group will complete two weeks of lower limb suspension and will receive no supplementation or nutritional education.
Intervention Type
Dietary Supplement
Intervention Name(s)
Profile Perform
Intervention Description
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
Other
Intervention Name(s)
Lower Limb Suspension
Intervention Description
This group will complete two weeks of lower limb suspension.
Primary Outcome Measure Information:
Title
Muscle Mass
Description
Whole body muscle mass (kg) will be measured using DXA while muscle cross-sectional area of the lower leg will be measured via pQCT
Time Frame
Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Secondary Outcome Measure Information:
Title
Muscle strength
Description
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
Time Frame
Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Other Pre-specified Outcome Measures:
Title
Volumetric bone mineral density
Description
Volumetric bone mineral density (mg/cm^2) at the 66% slice of the tibia will be measured using pQCT
Time Frame
Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Title
Bone Cross-Sectional Area
Description
Total bone cross sectional area (cm^2) at the 66% slice of the tibia will be measured
Time Frame
Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
South Dakota State University
City
Brookings
State/Province
South Dakota
ZIP/Postal Code
57007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population
We'll reach out to this number within 24 hrs