NCT05510440

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

June 20, 2022

Last Update Submit

January 2, 2023

Conditions

Exercise MyoglobinuriaCitrulline; Metabolic DisorderIron Metabolism DisordersInflammatory Response

Outcome Measures

Primary Outcomes (3)

  • 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

    14 days

  • 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.

    14 days

  • 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.

    14 days

Study Arms (2)

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

EXPERIMENTAL

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

Dietary Supplement: Alpha-amino acid derivatives

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

PLACEBO COMPARATOR

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

Dietary Supplement: Alpha-amino acid derivatives

Interventions

Alpha-amino acid derivativesDIETARY_SUPPLEMENT

Alpha-amino acid derivatives mainly citrulline will be used as a supplement to reduce kidneys and other internal organs damage

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

Eligibility Criteria

Age21 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of Gdańsk Faculty of Health Science

Gdansk, Pomeranian Voivodeship, 80-211, Poland

Location

Medical University of Gdańsk

Gdansk, 80-210, Poland

Location

MeSH Terms

Conditions

Metabolic DiseasesIron Metabolism Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Jędrzej Antosiewicz

    Medical University of Gdańsk, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jędrzej Antosiewicz

CONTACT

0048513046412jant@gumed.edu.pl

Jedrzej Antosiewicz

CONTACT

0048583491456jant@gumed.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

August 22, 2022

Study Start

March 1, 2023

Primary Completion

May 1, 2023

Study Completion

November 30, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Under reasonable request

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
for two years after the publication of the results
Access Criteria
Reasonable request

Locations

PL(2)