- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05183893
Effects of L-Citrulline or Citrulline-malate on Neuromuscular Performance in Resistance-trained Adults
Malate or Not?: Effects of L-Citrulline or Citrulline-malate on Neuromuscular Performance in Resistance-trained Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18011
- Jonatan Ruiz Ruiz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: L-Citrulline
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®).
|
5 g of L-citruline + 5 g of additives
|
Experimental: Experimental: Citrulline-malate
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®).
|
8g of citrulline-malate + 2 g of additives
|
Placebo Comparator: Placebo
10g of maltodextrin plus additives (Lifepro®).
|
10g of maltodextrine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal endurance strength
Time Frame: 1 hour
|
Maximal endurance strength of lower- and upper-body (squat and bench press exercises)
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal dynamic strength
Time Frame: 1 hour
|
Maximal dynamic strength of lower- and upper-body (squat and bench press exercises)
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Malate or Not Project
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuromuscular Performance
-
Universidad de GranadaRecruitingNeuromuscular PerformanceSpain
-
Universidade Federal do Rio Grande do NorteCompletedNeuromuscular Performance and BalanceBrazil
-
Universidade Federal do Rio Grande do NorteCompletedNeuromuscular Performance and BalanceBrazil
-
Universidade Federal do Rio Grande do NorteCompletedNeuromuscular Performance, Balance and FunctionBrazil
-
Universidade Federal do Rio Grande do NorteCompletedNeuromuscular Performance and BalanceBrazil
-
University of LjubljanaCompletedPhysical Performance | Ischemic Preconditioning | Neuromuscular Function | Tissue FlossingSlovenia
-
Shanghai Tongji Hospital, Tongji University School...Huashan HospitalCompletedDiagnostic Performance of Cardiovascular Autonomic NeuropathyChina
-
Atılım UniversityNot yet recruitingCognitive Performance | Physical PerformanceTurkey
-
PepsiCo Global R&DCompletedSkill Performance | Soccer Performance | Coffeeberry EffectsUnited Kingdom
-
PepsiCo Global R&DCompletedSleep | Cognitive Performance | Balance | Physical PerformanceAustralia
Clinical Trials on L-citrulline
-
Asklepion Pharmaceuticals, LLCVanderbilt UniversityCompletedHypertension, Pulmonary | Heart Defects, CongenitalUnited States
-
University of PittsburghCompleted
-
Asklepion Pharmaceuticals, LLCCompletedAtrial Septal Defect | Atrioventricular Septal Defect | Ventricular Septal DefectUnited States
-
Florida State UniversityCompletedHypertensionUnited States
-
University of Colorado, DenverCompleted
-
University of JordanUnknownType 2 Diabetes MellitusJordan
-
Florida State UniversityCompleted
-
Juliano CasonattoUnknown
-
European University CyprusCompleted