ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 42 for:    Recruiting, Not yet recruiting, Available Studies | "Anterior Cruciate Ligament Reconstruction"

Use of Glutamine for Recovery Muscle Strength

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03517254
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Sandra Hernández Valencia, Instituto Nacional de Rehabilitacion

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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Dietary Supplement: Glutamine Other: Strength training program Other: Placebo Other: Dietary recommendations Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: Glutamine and strength training program
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
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.
Other Name: Glutapak 10

Other: Strength training program
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.

Other: Dietary recommendations
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).

Placebo Comparator: Placebo and strength training program
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
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.

Other: Placebo
Maltodextrin powder to mimic glutamine,

Other: Dietary recommendations
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).




Primary Outcome Measures :
  1. 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) ]
    Measurement by computer dynamometer and expressed in Newton/meters at 60° angular speed.

  2. Change hamstring/quadriceps ratio [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session) ]
    Measurement by computer dynamometer and expressed in percentages at 60° angular speed.


Secondary Outcome Measures :
  1. Change in thigh circumference (In operated knee and the non-operated knee) [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session) ]
    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).

  2. Energy intake [ Time Frame: Baseline (admission to Sport Medicine), 3 and 6 weeks after the follow-up] ]
    Dietary interviews twice (24-h recall interviews) (Energy Kcal)

  3. Protein intake [ Time Frame: Baseline (admission to Sport Medicine), 3 and 6 weeks after the follow-up] ]
    Dietary interviews twice (24-h recall interviews) (protein, g/kg)

  4. Changes in blood glucose levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  5. Changes in total blood cholesterol levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  6. Changes in blood High Density Lipoprotein-Cholesterol (HDL-C) levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  7. Changes in blood Low density Lipoprotein-Cholesterol (LDL-C) levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  8. Changes in blood triglycerides levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  9. Changes in blood Aspartate aminotransferase (AST) levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  10. Changes in blood alanine aminotransferase (ALT) levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  11. Changes in blood Alkaline phosphatase (ALP) levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.

  12. Changes in blood Gamma-glutamyl transferase (GGT) levels [ Time Frame: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517254


Contacts
Contact: Sandra Hernández Valencia, MSc +525559991000 ext 15212 sandrahv710@gmail.com
Contact: Saúl León Ballesteros, MD, MSc. +525559991000 ext 15212 saulno1@yahoo.com

Locations
Mexico
Instituto Nacional de Rehabilitación Recruiting
Mexico City, Mexico, 14389
Contact: Sandra Hernández Valencia, MSc    +5255 5999-1000 ext 15212    sandrahv710@gmail.com   
Contact: Saúl León Ballesteros, MD, MSc    +5255 5999-1000 ext 15212    saulno1@yahoo.com   
Principal Investigator: Sandra Hernández Valencia, MSc,PhD (c)         
Principal Investigator: Saúl León, MD,MSc         
Sub-Investigator: Laura Moreno Altamirano, MD,MSc,PhD         
Sub-Investigator: Patricia Clark Peralta, MD,MSc,PhD         
Sub-Investigator: Guadalupe Gomez Pineda, MD         
Sub-Investigator: Juan Manuel Mejía Aranguré, MD,MSc,PhD         
Sub-Investigator: Rebeca Salas Romero, MSc         
Sub-Investigator: Andrea Pegueros Pérez, MSc         
Sponsors and Collaborators
Instituto Nacional de Rehabilitacion
Universidad Nacional Autonoma de Mexico
Investigators
Study Director: Laura Moreno Altamirano, PhD Universidad Nacional Autonoma de Mexico

Publications:
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
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.
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.

Responsible Party: Sandra Hernández Valencia, Principal investigator, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier: NCT03517254     History of Changes
Other Study ID Numbers: 47/16
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandra Hernández Valencia, Instituto Nacional de Rehabilitacion:
Glutamine,