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Supplementation With Altha-aminoacids and Systemiec Inflammatory Response in Long-distance Runners.

Primary Purpose

Exercise Myoglobinuria, Citrulline; Metabolic Disorder, Iron Metabolism Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Alpha-amino acid derivatives
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Exercise Myoglobinuria

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men over 21 years of age with good health confirmed in a medical examination,
  • training long runs with a confirmed minimum of five participation and completion of ultra-long runs (>42km)

Exclusion Criteria:

  • neuromuscular diseases,
  • cardiovascular disorders,
  • cancer,
  • hyperparathyroidism and thyroid,
  • dementia disorders and other diseases of the nervous and circulatory systems that may significantly contribute to problems with the implementation of research tasks

Sites / Locations

  • Medical University of Gdańsk Faculty of Health Science
  • Medical University of Gdańsk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Effect of citrulline supplementation combined with long distance running on systemic inflammation

Effect of placebo supplementation combined with long distance running on systemic inflammation

Arm Description

14-day protocol of supplementation with 6 g of citrulline.

14-day protocol of supplementation with 6 g of placebo.

Outcomes

Primary Outcome Measures

Systemic inflammation
Determining whether the 14-day protocol of supplementation with 6 g of citrulline contributes to the reduction of the inflammatory response, concentration of serum proinflammatory cytokines will be measured by multiplex technique
Post workout kidney damage ,
Determining whether the 14-day protocol of supplementation with 6 g of citrulline contributes to kidney damage induced by running, concentration of serum and urine markers of kidney function will be measured by standard methods.
Internal organe damage
Determining whether the 14-day protocol of supplementation with 6 g of citrulline contributes to the reduction internal organs damage induced by running effort, concentration of serum markers of heart, liver, and kidney and skeletal muscle damage will be measured by multiplex technique.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2022
Last Updated
January 2, 2023
Sponsor
Medical University of Gdansk
Collaborators
Gdansk University of Physical Education and Sport
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1. Study Identification

Unique Protocol Identification Number
NCT05510440
Brief Title
Supplementation With Altha-aminoacids and Systemiec Inflammatory Response in Long-distance Runners.
Official Title
Effect of Supplementation With Alpha-amino Acid Derivatives on the Level of Systemic Inflammatory Response and Post-workout Kidney Damage in Long Distance Runners
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Gdansk
Collaborators
Gdansk University of Physical Education and Sport

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is also noteworthy that the imbalance between the production, supply and elimination of especially α-amino acids may contribute to the intensification of the inflammatory response and the subsequent burden of the renal tubules, which may result in damage and developing chronic renal failure. Among the many amino acids used in sports, arginine and its metabolites deserve special attention. The role of arginine appears to increase in specific physiological states associated with disease, injury or significant strain on the body, leading to an increase in the rate of catabolic transformation. Arginine plays a significant role in protein biosynthesis and detoxification processes related to ammonia removal and urea formation .
Detailed Description
Subject and purpose of the project. Both in sport and medicine, methods are constantly being sought that can significantly contribute to improving the ability of tissues to perform their functions. A wide range of interests include various supplementation and training protocols. In a significant way, they are to contribute to the reduction of negative post-workout changes, protecting the athlete's tissues and organs from the debilitating effect of efforts of very long duration and high intensity. Commonly, in sports with a long duration of effort, supplementation with amino acid complexes is used, the purpose of which is to support both the metabolism of working muscles and provide building materials necessary for the functioning of muscle fibers. It was found that maintaining a proper supply of amino acids is one of the important factors protecting the human body against excessive intensification of catabolic processes. It is also noteworthy that the imbalance between the production, supply and elimination of especially α-amino acids may contribute to the intensification of the inflammatory response and the subsequent burden of the renal tubules, which may result in damage and developing chronic renal failure. Among the many amino acids used in sports, arginine and its metabolites deserve special attention. The role of arginine appears to increase in specific physiological states associated with disease, injury or significant strain on the body, leading to an increase in the rate of catabolic transformation Arginine plays a significant role in protein biosynthesis and detoxification processes related to ammonia removal and urea formation In addition, it was found that arginine is involved in the synthesis of proline, and may have a special effect on the body of athletes: creatine, nitric oxide, agmatine, ornithine, citrulline and glutamate. Attention is also drawn to the possible relationship between arginine and the secretion of endogenous growth hormone, insulin and glucagon . It is noteworthy that as a result of digestion, only 50% of arginine consumed with the diet after its release from proteins enters the blood, while 40% is broken down in the small intestine as a result of arginase . Part of the arginine pool in the blood plasma may come from the conversion of citrulline found in food. In cells, arginine transport takes place via specific membrane conveyors and is competently inhibited by selected NOS inhibitors (nitric oxide synthesis) and lysine, ornithine and canvaaine. In the liver, it participates in important detoxification processes, taking part in the urea cycle, while in vascular endothelial cells it stimulates the synthesis of nitric oxide. The dietary supply of arginine, unfortunately, is not effective. A much greater increase in its content in blood plasma is observed in the case of the use of an increased arginine precursor - citrulline. This means that thanks to the correct content of citrulline in the diet, it is possible to normalize the concentration of arginine in the body. In the case of physical activity itself, however, it seems more important that the high supply of citrulline in the diet may translate into an increase in oxygen consumption by tissues, improvement of strength capabilities, but what is very important, it may have a positive effect on bicarbonate reuptake, which is an exponent of normal kidney function. In addition, by limiting muscle damage and the breakdown of muscle fibers, the myoglobin content in the urine is reduced. In turn, its high concentration (>35 ng / ml or above 17 μg / g creatinine) is considered an important factor responsible for post-workout kidney damage. Suplementacjand citrulline in the case of ultramarathoners in terms of kidney function seems to be a very beneficial solution. The transformation of citrulline into arginine may translate into an increase in the concentration of nitrous oxide in the musculature of the renal vessels, which reduces the risk of ischemic changes developing in the kidney structure itself. Summing up the above properties of citrulline and the achievable benefits of its use, the subject of a smaller research project is to determine the effect of citrulline supplementation on the level of generalized inflammatory reaction induced by ultralong physical exertion. The aim of the entire research project is to try to show the phenomenon of post-workout kidney damage occurring in ultralong runners, as well as to illustrate the need to take (supplementation) actions aimed at protecting the kidneys, especially against toxic imbalance in the turnover of amino acids and the intensification of the harmful inflammatory response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Myoglobinuria, Citrulline; Metabolic Disorder, Iron Metabolism Disorders, Inflammatory Response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effect of citrulline supplementation combined with long distance running on systemic inflammation
Arm Type
Experimental
Arm Description
14-day protocol of supplementation with 6 g of citrulline.
Arm Title
Effect of placebo supplementation combined with long distance running on systemic inflammation
Arm Type
Placebo Comparator
Arm Description
14-day protocol of supplementation with 6 g of placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha-amino acid derivatives
Intervention Description
Alpha-amino acid derivatives mainly citrulline will be used as a supplement to reduce kidneys and other internal organs damage
Primary Outcome Measure Information:
Title
Systemic inflammation
Description
Determining whether the 14-day protocol of supplementation with 6 g of citrulline contributes to the reduction of the inflammatory response, concentration of serum proinflammatory cytokines will be measured by multiplex technique
Time Frame
14 days
Title
Post workout kidney damage ,
Description
Determining whether the 14-day protocol of supplementation with 6 g of citrulline contributes to kidney damage induced by running, concentration of serum and urine markers of kidney function will be measured by standard methods.
Time Frame
14 days
Title
Internal organe damage
Description
Determining whether the 14-day protocol of supplementation with 6 g of citrulline contributes to the reduction internal organs damage induced by running effort, concentration of serum markers of heart, liver, and kidney and skeletal muscle damage will be measured by multiplex technique.
Time Frame
14 days

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men over 21 years of age with good health confirmed in a medical examination, training long runs with a confirmed minimum of five participation and completion of ultra-long runs (>42km) Exclusion Criteria: neuromuscular diseases, cardiovascular disorders, cancer, hyperparathyroidism and thyroid, dementia disorders and other diseases of the nervous and circulatory systems that may significantly contribute to problems with the implementation of research tasks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jędrzej Antosiewicz
Phone
0048513046412
Email
jant@gumed.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Jedrzej Antosiewicz
Phone
0048583491456
Email
jant@gumed.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jędrzej Antosiewicz
Organizational Affiliation
Medical University of Gdańsk, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Gdańsk Faculty of Health Science
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Medical University of Gdańsk
City
Gdańsk
ZIP/Postal Code
80-210
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jedrzej Antosiewicz, Ph.D.
Phone
0048 513046412
Email
jant@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Jedrzej Antosiewicz, Ph.D.
Phone
0048 58 3491456
Email
jant@gumed.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Under reasonable request
IPD Sharing Time Frame
for two years after the publication of the results
IPD Sharing Access Criteria
Reasonable request

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Supplementation With Altha-aminoacids and Systemiec Inflammatory Response in Long-distance Runners.

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