An interventional study of Profile Perform and Lower Limb Suspension in Disuse Atrophy, sponsored by South Dakota State University. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by South Dakota State University · Not applicable, Interventional, and Treatment
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Among 25 studies in Muscular Disorders, Atrophic with a site in United States — 5 open to participants now, 8 under way, 1 of them phase 3. Muscular Disorders, Atrophic · United States.
Among the 25 studies in Muscular Disorders, Atrophic with a site in United States, this one is the 12th largest by enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2018, is one of 8 with no phase, and was the 10th registered.
56 studies on the registry are indexed under Muscular Disorders, Atrophic; 12 are open to participants now.
Browse Muscular Disorders, Atrophic studies →5 of the 25 studies in Muscular Disorders, Atrophic with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–80
Indiana University · Sites in United States
Ages 18–44 · Men only · Healthy volunteers
United States Army Research Institute of Environmental Medicine · Sites in United States
Ages 17–39 · Healthy volunteers
Brigham and Women's Hospital · Sites in United States
Ages 18+
Vertex Pharmaceuticals Incorporated · Sites in United States, Australia, Belgium and 5 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Muscular Disorders, Atrophic studies recruiting now, 3 set no upper age limit and 4 stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 25 Years · all sexes · healthy volunteers too.
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25 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 5
First in 1995; this study’s year is marked. 2 started in 2018.
This study's enrollment of 32 is above the median of 24 across 49 interventional studies indexed under Muscular Disorders, Atrophic.
Median enrollment 33 across the 22 interventional studies, 40 across the 2 observational. Of the 13 that completed or were terminated, 6 (46%) have results posted.
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14 of 25 have an industry lead sponsor. The 10 most frequent:
South Dakota State University is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
South Dakota State University has 1 study filed under Muscular Disorders, Atrophic — fewer than ten, so there is no comparison to draw.
2 of the studies in Muscular Disorders, Atrophic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07161973Indiana UniversityEffect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle in Young Healthy Men | 2026-12-31 |
| NCT06185764Vertex Pharmaceuticals IncorporatedA Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) | 2027-02-02 |
Add all 2 to your calendar (.ics) → With an account.
Among the 25 studies in Muscular Disorders, Atrophic with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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Exclusion Criteria:
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
Participants in this group will complete two weeks of lower limb suspension and will receive no supplementation or nutritional education.
Other: Lower Limb Suspension
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.
This group will complete two weeks of lower limb suspension.
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
Time frame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
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
Time frame: Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension
Volumetric bone mineral density
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
Bone Cross-Sectional Area
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Mar 2022, 49 months.
Of 19 interventional studies with no phase under Muscular Disorders, Atrophic, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's 49 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Muscular Disorders, Atrophic →
South Dakota State University