Use of Glutamine for Recovery Muscle Strength

NCT03517254 | Unknown

• 1 other identifier: 47/16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Glutamine,

Outcome Measures

Primary Outcomes (2)

• Change in torque peak of quadriceps femoris and hamstring

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

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

• Change hamstring/quadriceps ratio

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

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

Secondary Outcomes (12)

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

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

• Energy intake

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

• Protein intake

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

• Changes in blood glucose levels

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

• Changes in total blood cholesterol levels

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

Study Arms (2)

Glutamine and strength training program

EXPERIMENTAL

Three 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.

Dietary Supplement: Glutamine; Other: Strength training program; Other: Dietary recommendations

Placebo and strength training program

PLACEBO COMPARATOR

Three 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.

Other: Strength training program; Other: Placebo; Other: Dietary recommendations

Interventions

Glutamine DIETARY_SUPPLEMENT

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.

Also known as: Glutapak 10

Glutamine and strength training program

Strength training program OTHER

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.

Glutamine and strength training program; Placebo and strength training program

Placebo OTHER

Maltodextrin powder to mimic glutamine,

Placebo and strength training program

Dietary recommendations OTHER

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).

Glutamine and strength training program; Placebo and strength training program

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Instituto Nacional de Rehabilitación

Mexico City, 14389, Mexico

Location

Related Publications (20)

• 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.

  PMID: 25148530 BACKGROUND

• 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.

  PMID: 20660401 BACKGROUND

• 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.

  PMID: 22402434 BACKGROUND

• 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.

  PMID: 23669818 BACKGROUND

• 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.

  PMID: 24067150 BACKGROUND

• 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.

  PMID: 23238669 BACKGROUND

• 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.

  PMID: 18296991 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16235401 BACKGROUND

• 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.

  PMID: 20710097 BACKGROUND

• 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.

  PMID: 23134885 BACKGROUND

• 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.

  PMID: 25169440 BACKGROUND

• 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.

  PMID: 16917926 BACKGROUND

• 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.

  PMID: 23851404 BACKGROUND

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

  PMID: 23016081 BACKGROUND

• Agostini F, Biolo G. Effect of physical activity on glutamine metabolism. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):58-64. doi: 10.1097/MCO.0b013e328332f946.

  PMID: 19841583 BACKGROUND

• Piattoly T, Parish TR, Welsch MA. L-Glutamine Supplementation: effects on endurance, power and recovery. Curr Top Nutraceutical Res 11(1-2): 55-62, 2013.

  BACKGROUND

• Hernandez Valencia SE, Mendez Sanchez L, Clark P, Moreno Altamirano L, Mejia Arangure JM. [GLUTAMINE AS AN AID IN THE RECOVERY OF MUSCLE STRENGTH: SYSTEMATIC REVIEW OF LITERATURE]. Nutr Hosp. 2015 Oct 1;32(4):1443-53. doi: 10.3305/nh.2015.32.4.9321. Spanish.

  PMID: 26545503 BACKGROUND

• Legault Z, Bagnall N, Kimmerly DS. The Influence of Oral L-Glutamine Supplementation on Muscle Strength Recovery and Soreness Following Unilateral Knee Extension Eccentric Exercise. Int J Sport Nutr Exerc Metab. 2015 Oct;25(5):417-26. doi: 10.1123/ijsnem.2014-0209. Epub 2015 Mar 26.

  PMID: 25811544 BACKGROUND

• Waddell D Fredricks K. Effects of a Glutamine Supplement on the Skeletal Muscle Contractile Force of Mice. Am J Undergraduate Res 4:11-18, 2005.

  BACKGROUND

MeSH Terms

Interventions

Glutamine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Laura Moreno Altamirano, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 7, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

ME (1)