Neuromuscular PerformanceNCT05183893
Effects of L-Citrulline or Citrulline-malate on Neuromuscular Performance in Resistance-trained Adults
A study testing L-citrulline and Citrulline-malate in people with Neuromuscular Performance, run by Universidad de Granada at 1 site in Spain.
Trial summary
The main aim of this study is to compare the effects of L-Citrulline vs. Citrulline-malate on neuromuscular performance (maximal dynamic strength and maximal endurance strength) in resistance-trained adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Performance
- What is being tested?
- L-citrulline and Citrulline-malate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female
- Ages 18-30years
- BMI: 18-30.0 kg/m2
- Stable weight over the last 3 months (body weight changes<3kg)
- Previous experience in resistance training (i.e., at least 1 year with a frequency of two or more training sessions per week),
- Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.
Who cannot join
- History of chronic diseases (renal disease, diabetes, cardiovascular disease, cancer, VIH, hepatic disease, food disorders)
- Pregnant, planning to become pregnant, or breastfeeding
- Have been treated previously or during the study period with prescription drugs:
- antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
- Allergy/intolerance to any ingredient of the dietary supplements.
- Chronic consumers of dietary NO-precursors dietary supplements (citrulline malate, arginine, nitrates).
- Any non-controlled medical condition which could influence results or could be worsened by the participation in the study.
- Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malate or Not?: Effects of L-Citrulline or Citrulline-malate on Neuromuscular Performance in Resistance-trained Adults
The main aim of this study is to compare the effects of L-Citrulline vs. Citrulline-malate on neuromuscular performance (maximal dynamic strength and maximal endurance strength) in resistance-trained adults.
Read the detailed description
Nitric oxide (NO) is a ubiquitous gaseous molecule that plays a critical role in the regulation of cardiovascular function and in the signaling of multiple cellular processes. Specifically, NO could reduce the oxygen cost of exercise and adenosine triphosphate (ATP) in the production of muscle contractile force, improving calcium handling, glucose uptake and mitochondrial efficiency in muscle fibers. Therefore, it has been suggested that increasing the availability of NO through the oral intake of food and nutritional supplements may be useful to delay the onset of fatigue and improve performance in high-intensity efforts.
L-citrulline is a nonessential amino acid involved in the urea cycle that acts as an endogenous precursor of L-arginine, being a more efficient alternative to L-arginine to increase the plasma concentration of L-arginine through the nitric oxide synthase (NOS) pathway.
On the other hand, citrulline malate is an organic salt of L-citrulline and malate which has been shown to exert a small but significant ergogenic effect in different high-intensity efforts compared to a placebo. However, no study to date has compared L-citrulline VS. citrulline malate to assess whether there is an additive effect from malate to exercise performance.
50 resistance-trained adults (50% women) will be randomized into three conditions (L-citrulline, citrulline-malate and placebo conditions) with 48 hours of separation between conditions. 48h previous to the randomization the participants will perform a familiarization to avoid the learning effects.
Each evaluation day will conform to the following tests:
- Maximal dynamic strength of lower- and upper-body
- Maximal endurance strength of lower- and upper-body
- Conditions
- Neuromuscular Performance
- Being tested
- L-citrulline, Citrulline-malate, Placebo
- Keywords
- nitric oxide, dietary supplement, resistance training, citrulline malate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-citrullineDietary supplement
5 g of L-citruline + 5 g of additives
Citrulline-malateDietary supplement
8g of citrulline-malate + 2 g of additives
PlaceboDietary supplement
10g of maltodextrine
| Study group | Role | What they receive |
|---|---|---|
| Experimental: L-Citrulline | Experimental | 5 g of L-citruline + 5 g of additives. The dose to be administered is that recommended on the labeling and nutritional information of the product, which has been produced under GMP procedures and approved by the EFSA (Lifepro®). Receives: Dietary Supplement: L-citrulline |
| Experimental: Citrulline-malate | Experimental | 8g of citrulline-malate + 2 g of additives. The dose to be administered is that recommended on the labeling and nutritional information of the products which has been produced under GMP procedures and approved by the EFSA (Lifepro®). Receives: Dietary Supplement: Citrulline-malate |
| Placebo | Placebo comparator | 10g of maltodextrin plus additives (Lifepro®). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal endurance strength
Maximal endurance strength of lower- and upper-body (squat and bench press exercises)
Measured: 1 hour
Secondary outcomes (1)
Maximal dynamic strength
Maximal dynamic strength of lower- and upper-body (squat and bench press exercises)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Feb 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Jurado-Fasoli, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183893
- Sponsor's protocol ID
- Malate or Not Project
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martin-Olmedo JJ, Miras-Moreno S, Cuadra-Montes K, Garcia-Ramos A, Ruiz JR, Jurado-Fasoli L. Malate or Not? Acute Effects of L-Citrulline Versus Citrulline Malate on Neuromuscular Performance in Young, Trained Adults: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial. Int J Sport Nutr Exerc Metab. 2024 Dec 11;35(2):89-98. doi: 10.1123/ijsnem.2024-0006. Print 2025 Mar 1.
PubMed 39662304
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malate or Not?: Effects of L-Citrulline or Citrulline-malate on Neuromuscular Performance in Resistance-trained Adults
- ClinicalTrials.gov ID
- NCT05183893
- Acronym / sponsor ID
- Malate or Not Project
- Conditions
- Neuromuscular Performance
- Keywords
- nitric oxide, dietary supplement, resistance training, citrulline malate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to compare the effects of L-Citrulline vs. Citrulline-malate on neuromuscular performance (maximal dynamic strength and maximal endurance strength) in resistance-trained adults.
Detailed description
Nitric oxide (NO) is a ubiquitous gaseous molecule that plays a critical role in the regulation of cardiovascular function and in the signaling of multiple cellular processes. Specifically, NO could reduce the oxygen cost of exercise and adenosine triphosphate (ATP) in the production of muscle contractile force, improving calcium handling, glucose uptake and mitochondrial efficiency in muscle fibers. Therefore, it has been suggested that increasing the availability of NO through the oral intake of food and nutritional supplements may be useful to delay the onset of fatigue and improve performance in high-intensity efforts.
L-citrulline is a nonessential amino acid involved in the urea cycle that acts as an endogenous precursor of L-arginine, being a more efficient alternative to L-arginine to increase the plasma concentration of L-arginine through the nitric oxide synthase (NOS) pathway.
On the other hand, citrulline malate is an organic salt of L-citrulline and malate which has been shown to exert a small but significant ergogenic effect in different high-intensity efforts compared to a placebo. However, no study to date has compared L-citrulline VS. citrulline malate to assess whether there is an additive effect from malate to exercise performance.
50 resistance-trained adults (50% women) will be randomized into three conditions (L-citrulline, citrulline-malate and placebo conditions) with 48 hours of separation between conditions. 48h previous to the randomization the participants will perform a familiarization to avoid the learning effects.
Each evaluation day will conform to the following tests:
- Maximal dynamic strength of lower- and upper-body
- Maximal endurance strength of lower- and upper-body
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: L-Citrulline | Experimental | Dietary Supplement: L-citrulline5 g of L-citruline + 5 g of additives. The dose to be administered is that recommended on the labeling and nutritional information of the product, which has been produced under GMP procedures and approved by the EFSA (Lifepro®). |
| Experimental: Citrulline-malate | Experimental | Dietary Supplement: Citrulline-malate8g of citrulline-malate + 2 g of additives. The dose to be administered is that recommended on the labeling and nutritional information of the products which has been produced under GMP procedures and approved by the EFSA (Lifepro®). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo10g of maltodextrin plus additives (Lifepro®). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female
- Ages 18-30years
- BMI: 18-30.0 kg/m2
- Stable weight over the last 3 months (body weight changes<3kg)
- Previous experience in resistance training (i.e., at least 1 year with a frequency of two or more training sessions per week),
Key exclusion criteria (8 listed)
- History of chronic diseases (renal disease, diabetes, cardiovascular disease, cancer, VIH, hepatic disease, food disorders)
- Pregnant, planning to become pregnant, or breastfeeding
- Have been treated previously or during the study period with prescription drugs:
- antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
- Allergy/intolerance to any ingredient of the dietary supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-citrulline5 g of L-citruline + 5 g of additives | Dietary supplement | Experimental: L-Citrulline |
| Citrulline-malate8g of citrulline-malate + 2 g of additives | Dietary supplement | Experimental: Citrulline-malate |
| Placebo10g of maltodextrine | Dietary supplement | Placebo |
Primary outcome
Maximal endurance strength
Time frame: 1 hour
Maximal endurance strength of lower- and upper-body (squat and bench press exercises)
1 secondary outcome
Maximal dynamic strength
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 39662304Martin-Olmedo JJ, Miras-Moreno S, Cuadra-Montes K, Garcia-Ramos A, Ruiz JR, Jurado-Fasoli L. Malate or Not? Acute Effects of L-Citrulline Versus Citrulline Malate on Neuromuscular Performance in Young, Trained Adults: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial. Int J Sport Nutr Exerc Metab. 2024 Dec 11;35(2):89-98. doi: 10.1123/ijsnem.2024-0006. Print 2025 Mar 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-citrulline and Citrulline-malate in people with Neuromuscular Performance, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal endurance strength (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.