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Anterior Cruciate Ligament ReconstructionNCT03517254

Use of Glutamine for Recovery Muscle Strength

A study testing Glutamine, Strength training program and Dietary recommendations in people with Anterior Cruciate Ligament Reconstruction, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

After an Anterior Cruciate Ligament Reconstruction by surgery, the most important muscle of the knee, called quadriceps femoral, loses strength in more than 60% of cases, which if not corrected can progress to osteoarthritis in up to 80% of patients, compromising their quality of life. Read more about this study

Who is it for?
Ages 20 to 50 years, men only
What is being tested?
Glutamine, Strength training program and Dietary recommendations
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteMexico
Study dates
1 Mar 2018to Dec 2023
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 20 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients between 15 to 19 weeks after surgical reconstruction of anterior cruciate ligament
  • Moderate loss of muscle strength of knee (assessment with computerized dynamometer)
  • Perform the training sessions in the hospital
  • No athletes
  • Index Body Mass: 20 - 30 kg/m²
  • Without consumption of supplements based on amino acids in the last 6 months
  • To sign informed consent letter

Who cannot join

  • Diabetes mellitus I or 2
  • Liver and renal diseases
  • Dyslipidemia
  • Glucocorticoid consumption
  • Active cancer
  • Glutamine allergy or intolerance
  • Planning to lose weight/go on special diet

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Rehabilitación

    Mexico City, 14389

Other trials in Mexico

About this study

Official title: Effect of Oral Complementation of Glutamine on Knee Strengths Indicators in Adult Patients With Anterior Cruciate Ligament Reconstruction. A Double-blinded, Randomized Controlled Trial

After an Anterior Cruciate Ligament Reconstruction by surgery, the most important muscle of the knee, called quadriceps femoral, loses strength in more than 60% of cases, which if not corrected can progress to osteoarthritis in up to 80% of patients, compromising their quality of life.

The main treatment for loss of muscle strength in these patients is rehabilitation which includes strength and endurance exercises.However, in some cases, amino acids such as Glutamine (Gln) have been employed as an aid to recover muscle strength, but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the oral complementation with Glutamine in combination with strength and resistance training can improve the muscle strength of the quadriceps femoral in patients with anterior cruciate ligament reconstruction compared with those receiving a placebo after six weeks of intervention.

Read the detailed description

The study design is a randomized, double-blind and controlled trial. A total of 50 adult men will be recruited from medical departments of the National Institute of Rehabilitation in Mexico City.

Patients: Fifty men 20 to 50 years old, between 15 to 19 weeks after surgical reconstruction of anterior cruciate ligament and moderate loss of muscle strength of knee (assessment with computerized dynamometer), will be recruited from the Sport Rehabilitation department, and the treatment will be carried out in the Sport Medicine area, both of the National Institute of Rehabilitation in Mexico City. Patients with diabetes, obesity, hypertension, kidney or liver diseases or with glucocorticoid treatment, and athletes will not be included.

Intervention: The sample will be randomized in two groups. At the beginning and at the end of the training session, the experimental group will receive 10 grams of glutamine, and the control group will receive 10 grams of placebo (maltodextrin), both dissolved in 120 milliliters of water and all participants will not be aware of the supplement content.

Both groups will participate in the same standardized resistance training program, to ensure progression (or regression if necessary) to all training components and adherence to the intervention, each participant will do the training program in a therapeutic gym of Sport Medicine area three times per week, during 6 weeks of follow-up. One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knees, and 12 repetitions for knees with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.

All participants, irrespective of the supplement that they receive, will be closely monitored by a physician specialist in Sport Medicine and a nutritionist, who will give a dietary program to standardize protein consumption. Status nutritional will be assessed according to Body Mass Index [(BMI) 19.9-24.9, 25-29.9].

Muscle strength will be measured by a computer dynamometer. The reliability of the dynamometry will be evaluated by Intraclass Correlation Coefficient (ICC). Thigh circumference will be measured by a anthropometric technique (Nutritionists certified by the International Society for the Advance of Kinanthropometry in level one, will carry out the measurement). Fasting glucose, lipid profile and liver function test will be carried out in the clinical laboratory of National Institute of Rehabilitation. The measurements are going to be held twice; before the first training session, and 6 weeks after.

For each participant the study duration will start in the first training session until 6 weeks after. Endpoints assessments will be performed at baseline (2 days before starting the training program) and after 6 weeks of follow-up (2 days after the last training session). Data will be collected by study investigators blinded to the allocation of the participants.

Comparison: The control group will receive maltodextrin powder (placebo) dissolved in 120 milliliters of water. The placebo will be inside gray envelopes, in the same manner that the glutamine was administered.

Outcomes: The main outcome is to change the strength of quadriceps femoris (assessment by isokinetic dynamometer).

Being tested
Glutamine, Strength training program, Placebo, Dietary recommendations
Keywords
Glutamine,

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlutamineDietary supplement

    Also called Glutapak 10

    At the beginning and at the end of the training session, the experimental group will receive by mouth 15 grams of glutamine dissolved in 120 milliliters of water. The aminoacid will be inside gray envelopes.

  • Strength training programOther

    One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knee, and 12 repetitions for knee with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.

  • PlaceboOther

    Maltodextrin powder to mimic glutamine,

  • Dietary recommendationsOther

    All participants, irrespective of the supplement that they receive, will be closely monitored by a nutritionist, who will give dietary recommendations to standardize protein consumption (1.2 gr/kg weight). Status nutritional will be assessed according to BMI ( 19.9-24.9, 25-29.9).

Study groups in NCT03517254
Study groupRoleWhat they receive
Glutamine and strength training programExperimentalThree times per week, standardized and supervised resistance training by physicians will be conducted at the National Institute of Rehabilitation for 6 weeks of follow up. At the beginning and at the end of the training session, the experimental group will receive by mouth 10 grams of glutamine dissolved in 120 milliliters of water, all participants and team of researchers will not be aware of the supplement.
Receives: Dietary Supplement: Glutamine; Other: Strength training program; Other: Dietary recommendations
Placebo and strength training programPlacebo comparatorThree times per week a standardized and supervised resistance training by physicians will be conducted at the National Institute of Rehabilitation for 6 weeks after discharge. At the beginning and at the end of the training session, the placebo group will receive by mouth10 grams of maltodextrin dissolved in 120 milliliters of water. All participants and team of researchers will not be aware of the supplement content.
Receives: Other: Strength training program; Other: Placebo; Other: Dietary recommendations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in torque peak of quadriceps femoris and hamstring

    Measurement by computer dynamometer and expressed in Newton/meters at 60° angular speed.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session)

  2. Change hamstring/quadriceps ratio

    Measurement by computer dynamometer and expressed in percentages at 60° angular speed.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session)

Secondary outcomes (12)

  1. Change in thigh circumference (In operated knee and the non-operated knee)

    Thigh circumference (centimeters) evaluated by fiberglass tape measure according to the technique that has been established by the International Society for the Advancement of Kinanthropomethry (ISAK).

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session)

  2. Energy intake

    Dietary interviews twice (24-h recall interviews) (Energy Kcal)

    Measured: Baseline (admission to Sport Medicine), 3 and 6 weeks after the follow-up]

  3. Protein intake

    Dietary interviews twice (24-h recall interviews) (protein, g/kg)

    Measured: Baseline (admission to Sport Medicine), 3 and 6 weeks after the follow-up]

  4. Changes in blood glucose levels

    A sample of 5 milliliters of blood will be taken from patients with 8 hours of fasting. The quantification of blood glucose levels will be through the hexokinase method, which is used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  5. Changes in total blood cholesterol levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting. The quantification of total blood cholesterol levels will be through the CHOL method, which is used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  6. Changes in blood High Density Lipoprotein-Cholesterol (HDL-C) levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting. The quantification of blood HDL-C levels will be through AHDL-Method, which is used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  7. Changes in blood Low density Lipoprotein-Cholesterol (LDL-C) levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting. The quantification of blood LDL-C levels will be through ALDL-Method, used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  8. Changes in blood triglycerides levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting. The quantification of blood triglycerides levels will be through TGL-Method, used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  9. Changes in blood Aspartate aminotransferase (AST) levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting. The quantification of blood Aspartate aminotransferase (AST) levels will be through AST-Method, used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  10. Changes in blood alanine aminotransferase (ALT) levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting. The quantification of blood Alanine aminotransferase (ALT) levels will be through ALTI-Method, used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  11. Changes in blood Alkaline phosphatase (ALP) levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting, for the quantification of blood Alkaline phosphatase (ALP) levels through method used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

  12. Changes in blood Gamma-glutamyl transferase (GGT) levels

    A sample of 5 milliliters of blood will be taken from patients with 12 hours of fasting. The quantification of blood Gamma-glutamyl transferase (GGT) levels will be through GGT-Method, used by Dimension clinical chemistry system.

    Measured: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2018
  2. Study start1 Mar 2018
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03517254
Sponsor's protocol ID
47/16
Status last verified
Apr 2022
First submitted
5 Apr 2018
Last updated
29 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nordenvall R, Bahmanyar S, Adami J, Mattila VM, Fellander-Tsai L. Cruciate ligament reconstruction and risk of knee osteoarthritis: the association between cruciate ligament injury and post-traumatic osteoarthritis. a population based nationwide study in Sweden, 1987-2009. PLoS One. 2014 Aug 22;9(8):e104681. doi: 10.1371/journal.pone.0104681. eCollection 2014.

    PubMed 25148530

  • Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.

    PubMed 20660401

  • Adams D, Logerstedt DS, Hunter-Giordano A, Axe MJ, Snyder-Mackler L. Current concepts for anterior cruciate ligament reconstruction: a criterion-based rehabilitation progression. J Orthop Sports Phys Ther. 2012 Jul;42(7):601-14. doi: 10.2519/jospt.2012.3871. Epub 2012 Mar 8.

    PubMed 22402434

  • Hsiao SF, Chou PH, Hsu HC, Lue YJ. Changes of muscle mechanics associated with anterior cruciate ligament deficiency and reconstruction. J Strength Cond Res. 2014 Feb;28(2):390-400. doi: 10.1519/JSC.0b013e3182986cc1.

    PubMed 23669818

  • Thomas AC, Villwock M, Wojtys EM, Palmieri-Smith RM. Lower extremity muscle strength after anterior cruciate ligament injury and reconstruction. J Athl Train. 2013 Sep-Oct;48(5):610-20. doi: 10.4085/1062-6050-48.3.23. Epub 2013 Apr 18.

    PubMed 24067150

  • Zuka-Nowak K, Ogrodzka K, Chwala W, Niedzwiedzki L, Niedzwiedzki T. Kinetic and kinematic characteristics of natural velocity gait in anterior cruciate ligament-deficient patients. Int J Rehabil Res. 2013 Jun;36(2):152-61. doi: 10.1097/MRR.0b013e32835c79c5.

    PubMed 23238669

  • Orri JC, Darden GF. Technical report: Reliability and validity of the iSAM 9000 isokinetic dynamometer. J Strength Cond Res. 2008 Jan;22(1):310-7. doi: 10.1519/JSC.0b013e31815fa2c8.

    PubMed 18296991

  • Risberg MA, Lewek M, Snyder-MacKler L. A systematic review of evidence for anterior cruciate ligament rehabilitation: how much and what type?. Phys Ther Sport (5): 125-145, 2004

  • Trees AH, Howe TE, Dixon J, White L. Exercise for treating isolated anterior cruciate ligament injuries in adults. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD005316. doi: 10.1002/14651858.CD005316.pub2.

    PubMed 16235401

  • Eitzen I, Moksnes H, Snyder-Mackler L, Risberg MA. A progressive 5-week exercise therapy program leads to significant improvement in knee function early after anterior cruciate ligament injury. J Orthop Sports Phys Ther. 2010 Nov;40(11):705-21. doi: 10.2519/jospt.2010.3345.

    PubMed 20710097

  • Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.

    PubMed 23134885

  • Pasiakos SM, McLellan TM, Lieberman HR. The effects of protein supplements on muscle mass, strength, and aerobic and anaerobic power in healthy adults: a systematic review. Sports Med. 2015 Jan;45(1):111-31. doi: 10.1007/s40279-014-0242-2.

    PubMed 25169440

  • Holm L, Esmarck B, Mizuno M, Hansen H, Suetta C, Holmich P, Krogsgaard M, Kjaer M. The effect of protein and carbohydrate supplementation on strength training outcome of rehabilitation in ACL patients. J Orthop Res. 2006 Nov;24(11):2114-23. doi: 10.1002/jor.20147.

    PubMed 16917926

  • Eichner ER. Glutamine supplementation: overstaying its welcome. Curr Sports Med Rep. 2013 Jul-Aug;12(4):211-2. doi: 10.1249/JSR.0b013e31829b54c8. No abstract available.

    PubMed 23851404

  • Mason BC, Lavallee ME. Emerging supplements in sports. Sports Health. 2012 Mar;4(2):142-6. doi: 10.1177/1941738111428127.

    PubMed 23016081

Questions about this trial

What is this clinical trial studying?

A study testing Glutamine, Strength training program and Dietary recommendations in people with Anterior Cruciate Ligament Reconstruction, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Apr 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 Mexico. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Change in torque peak of quadriceps femoris and hamstring (time frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03517254, which also lists 20 linked publications.

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 29 Apr 2022.

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