NCT06938126

Brief Summary

In this randomized, double-blind, placebo-controlled trial we investigated the effects of combined L-arginine (Arg) and citrulline-malate (CM) supplementation on aerobic, anaerobic, and high-intensity interval training in healthy, physically active men. 46 healthy, physically active men were divided into three distinct exercise protocol groups: CrossFit group, the Wingate Anaerobic Test group, and the Harvard Step Test group. The CrossFit performance assessment involved the "Cindy" workout, a high-intensity protocol composed of bodyweight exercises organized in a set sequence: 5 pull-ups, 10 push-ups, and 15 squats. Participants were instructed to perform as many rounds as possible within 20 minutes. The Wingate Anaerobic test involved a 30-second all-out cycling test on a bike ergometer, while the Harvard Step Test The Harvard Step Test was conducted using a 51 cm high platform, with participants stepping at a rate of 30 steps per minute (one second up, one second down) for five minutes or until exhaustion. Each participant attended three separate laboratory sessions. The initial session served for familiarization with the test protocol to minimize learning effects. In the second and the third sessions, participants attended two measurement sessions, conducted in randomized order and under double-blind conditions, where they received either the dietary supplementation or a placebo. Each participant acted as their control, allowing for within-subject comparisons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 7, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

L-arginineCitrulline-malateSport-performanceCrossFit

Outcome Measures

Primary Outcomes (2)

  • Mechanical Power

    Maximal and mean mechanical power was assessed during the Wingate Anaerobic Test under both conditions (supplementation and placebo).

    Day 1 and Day 2

  • Fitness Score

    During the CrossFit exercise and the Harvard Step Test the primare measure of performance was a Fitness Score, which was calculated from the rounds completed for the CrossFit exercise and from the time duration and heart rate for the Harvard Step Test.

    Day 1 and Day 2

Secondary Outcomes (1)

  • Heart Rate

    Day 1 and Day 2

Study Arms (2)

Supplementation

EXPERIMENTAL

Supplementation of L-Arginine and Citrulline-malate as a liquid

Dietary Supplement: L-Arginine and Citrulline-Malate Supplementation

Placebo

PLACEBO COMPARATOR

Consumption of a placebo liquid

Dietary Supplement: Placebo consumption

Interventions

L-Arginine and Citrulline Malate supplementation was consumed as a liquid one single time to examine the acute effects on sport performance

Supplementation
Placebo consumptionDIETARY_SUPPLEMENT

Consumption of placebo as a liquid

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals identified as men could participate
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being healthy, physically active with no history of injuries or illnesses at the time of measurement or within the preceding six months

You may not qualify if:

  • consumption of any dietary supplements in the last six months to avoid confounding effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hungaria University of Sports Science

Budapest, 1124, Hungary

Location

Related Links

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Each participant acted as their control, allowing for within-subject comparisons. Each participant attended three separate laboratory sessions. Measurement sessions were conducted in randomized order and under double-blind conditions, where participants received either the dietary supplementation or a placebo.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 22, 2025

Study Start

October 1, 2023

Primary Completion

May 15, 2024

Study Completion

September 30, 2024

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

All individual data the are included in the study and support the statistical analysis

Shared Documents
STUDY PROTOCOL
Time Frame
from April 1, 2025 to December 31, 2025
Access Criteria
Data are available by the corresponding author

Available IPD Datasets

Individual Participant Data Set (TE-KEB/22/2023)Access

Locations