Rehabilitative Nutrition for Muscle Recovery From ACL ReconstructionNCT03492021
Protein in Feeding Strategies to Accelerate Muscle Recovery From ACL Reconstruction
A study testing Diet Intervention_AP-CPT and Diet Intervention_PP-PPT in people with Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction, run by University of Connecticut at 1 site in United States.
Trial summary
Musculoskeletal injury, particularly injuries requiring surgical repair, induce significant muscle atrophy, resulting in diminished physical function. The protein turnover-associated (diminished protein synthesis, elevated protein breakdown, negative net muscle protein balance) etiology of injury and surgical-induced… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction
- What is being tested?
- Diet Intervention_AP-CPT and Diet Intervention_PP-PPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 50 years of age
- identified as appropriate for study recruitment by their respective orthopedic surgeon
- undergoing their first anterior cruciate ligament (ACL) repair
- undergo ACL reconstruction under general anesthesia
- body mass indexes (BMIs) within normal to overweight ranges
Who cannot join
- reporting metabolic or cardiovascular abnormalities, food allergies, gastrointestinal disorders (i.e. lactose intolerance)
- use of nutritional/herbal/sports supplements including anabolic steroids, and tobacco products will be excluded from the study
- BMIs above 29.9
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Associates of Hartford
Hartford, Connecticut, 06106
About this study
Official title: The Role of Beef in Optimal Protein and Feeding Strategies to Accelerate Muscle Mass and Functional Recovery From Anterior Cruciate Ligament (ACL) Repair
Musculoskeletal injury, particularly injuries requiring surgical repair, induce significant muscle atrophy, resulting in diminished physical function. The protein turnover-associated (diminished protein synthesis, elevated protein breakdown, negative net muscle protein balance) etiology of injury and surgical-induced atrophy are, in part, similar to those observed with muscle wasting induced by hyper-catabolic and inflammatory conditions and prolonged periods of skeletal muscle disuse (e.g., cachexia and joint immobilization). Combining dietary strategies to optimize the anabolic properties of beef as a high quality protein source that provides essential amino acids prior to surgery and throughout post-surgery rehabilitation may attenuate muscle atrophy and accelerate the restoration of muscle function. This project will examine the efficacy of habitual consumption of a beef-based higher protein meal pattern and post-physical rehabilitation beef protein supplementation throughout post-surgical rehabilitation intervention on skeletal muscle function in response to anterior cruciate ligament (ACL) repair in healthy, physically active adults.
Stable isotope methodologies, proteomic analysis of muscle protein synthesis, and molecular assessments of skeletal muscle atrophy and remodeling will be assessed to evaluate the effects of increased protein intake, including consumption of a high quality beef-based protein supplement following patient physical therapy sessions on:
- Skeletal muscle protein fractional synthetic rates during and in recovery from surgery;
- Inflammatory, proteolytic, and anabolic intramuscular signaling during surgery and their association with skeletal muscle protein synthesis and muscle function;
- Muscle size and functional recovery;
- Duration to return to routine exercise, sport, or physical activity.
- Being tested
- Diet Intervention_AP-CPT, Diet Intervention_PP-PPT
- Keywords
- rehabilitative nutrition, protein, beef, ACL reconstruction, protein synthesis, proteolysis, muscle mass, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet Intervention_AP-CPTOther
Adequate Protein_Carbohydrate Post Therapy (AP-CPT) where protein intake will be 1 g/kg/d for the duration of the study .
Diet Intervention_PP-PPTOther
Optimal Protein_Protein Post Therapy (OP-PPT) with protein intake set at 2.0 g/kg/day for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Adequate Protein_Carbohydrate Post Therapy | Experimental | Diet Intervention - Adequate Protein (1.0 g/kg/d) - Carbohydrate Post Therapy [AP-CPT] Receives: Other: Diet Intervention_AP-CPT |
| Optimal Protein_Protein Post Therapy | Experimental | Diet Intervention - Optimal Protein (2.0 g/kg/d) - Protein Post Therapy [OP-PPT] Receives: Other: Diet Intervention_PP-PPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle protein fractional synthetic rates
Using stable isotope techniques skeletal muscle protein fractional synthetic rates will be determined
Measured: Following 16 weeks of physical rehabilitation post surgery for subjects in both diet intervention groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Feb 2018
- Primary completion31 Jul 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitative Nutrition for Muscle Recovery From ACL ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Associates of Hartford, United States Army Research Institute of Environmental Medicine, University of California, Berkeley
- Responsible party
- Principal investigator, Nancy Rodriguez, University of Connecticut
- Investigators
- Nancy R Rodriguez, PhD, Principal investigator, University of Connecticut-Storrs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492021
- Sponsor's protocol ID
- HHC-E-HHC-2016-0126
- Other IDs
- KFS63669550
- Status last verified
- Sep 2022
- First submitted
- 2 Apr 2018
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Beef in Optimal Protein and Feeding Strategies to Accelerate Muscle Mass and Functional Recovery From Anterior Cruciate Ligament (ACL) Repair
- ClinicalTrials.gov ID
- NCT03492021
- Acronym / sponsor ID
- HHC-E-HHC-2016-0126
- Keywords
- rehabilitative nutrition, protein, beef, ACL reconstruction, protein synthesis, proteolysis, muscle mass, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Orthopedic Associates of Hartford, United States Army Research Institute of Environmental Medicine, University of California, Berkeley
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Musculoskeletal injury, particularly injuries requiring surgical repair, induce significant muscle atrophy, resulting in diminished physical function. The protein turnover-associated (diminished protein synthesis, elevated protein breakdown, negative net muscle protein balance) etiology of injury and surgical-induced atrophy are, in part, similar to those observed with muscle wasting induced by hyper-catabolic and inflammatory conditions and prolonged periods of skeletal muscle disuse (e.g., cachexia and joint immobilization). Combining dietary strategies to optimize the anabolic properties of beef as a high quality protein source that provides essential amino acids prior to surgery and throughout post-surgery rehabilitation may attenuate muscle atrophy and accelerate the restoration of muscle function. This project will examine the efficacy of habitual consumption of a beef-based higher protein meal pattern and post-physical rehabilitation beef protein supplementation throughout post-surgical rehabilitation intervention on skeletal muscle function in response to anterior cruciate ligament (ACL) repair in healthy, physically active adults.
Stable isotope methodologies, proteomic analysis of muscle protein synthesis, and molecular assessments of skeletal muscle atrophy and remodeling will be assessed to evaluate the effects of increased protein intake, including consumption of a high quality beef-based protein supplement following patient physical therapy sessions on:
- Skeletal muscle protein fractional synthetic rates during and in recovery from surgery;
- Inflammatory, proteolytic, and anabolic intramuscular signaling during surgery and their association with skeletal muscle protein synthesis and muscle function;
- Muscle size and functional recovery;
- Duration to return to routine exercise, sport, or physical activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adequate Protein_Carbohydrate Post Therapy | Experimental | Other: Diet Intervention_AP-CPTDiet Intervention - Adequate Protein (1.0 g/kg/d) - Carbohydrate Post Therapy [AP-CPT] |
| Optimal Protein_Protein Post Therapy | Experimental | Other: Diet Intervention_PP-PPTDiet Intervention - Optimal Protein (2.0 g/kg/d) - Protein Post Therapy [OP-PPT] |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 50 years of age
- identified as appropriate for study recruitment by their respective orthopedic surgeon
- undergoing their first anterior cruciate ligament (ACL) repair
- undergo ACL reconstruction under general anesthesia
- body mass indexes (BMIs) within normal to overweight ranges
Key exclusion criteria (3 listed)
- reporting metabolic or cardiovascular abnormalities, food allergies, gastrointestinal disorders (i.e. lactose intolerance)
- use of nutritional/herbal/sports supplements including anabolic steroids, and tobacco products will be excluded from the study
- BMIs above 29.9
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet Intervention_AP-CPTAdequate Protein_Carbohydrate Post Therapy (AP-CPT) where protein intake will be 1 g/kg/d for the duration of the study . | Other | Adequate Protein_Carbohydrate Post Therapy |
| Diet Intervention_PP-PPTOptimal Protein_Protein Post Therapy (OP-PPT) with protein intake set at 2.0 g/kg/day for the duration of the study | Other | Optimal Protein_Protein Post Therapy |
Primary outcome
Skeletal muscle protein fractional synthetic rates
Time frame: Following 16 weeks of physical rehabilitation post surgery for subjects in both diet intervention groups.
Using stable isotope techniques skeletal muscle protein fractional synthetic rates will be determined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy R Rodriguez, PhD principal investigator
University of Connecticut-Storrs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Intervention_AP-CPT and Diet Intervention_PP-PPT in people with Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle protein fractional synthetic rates (time frame: Following 16 weeks of physical rehabilitation post surgery for subjects in both diet intervention groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.