Effect of L-citrulline & HIIT on Arterial Stiffness & MAFLD in Adolescents

Status Enrolling by invitation

Clinical Trial Summary

Obesity and metabolic dysfunction-associated fatty liver disease (MAFLD) accelerate the appearance of arterial stiffness due to inflammatory and oxidative stress mechanisms producing increased vascular tone and increasing the risk of cardiovascular disease. This arterial stiffness can be measured through pulse wave velocity (PWV). Obesity and MAFLD have multifactorial components, high fructose diet and sedentary lifestyle are causing the onset of these diseases earlier in life such as in adolescence. L-citrulline, a non-protein amino acid, has shown positive effects on improving nitric oxide synthesis which improves endothelial function, as well as results on the metabolic profile in MAFLD. High intensity interval training (HIIT) has also shown benefits on endothelial function improving the metabolic profile of people with obesity and MAFLD with the advantage of decreasing the time required to perform the physical activity. A clinical study will be conducted with 45 adolescents (15-19 years old) with MAFLD and the participants will be divided into 3 groups to perform HIIT and supplement with citrulline or placebo for 12 weeks.

Clinical Trial Description

The investigators hypothesize that citrulline and HIIT have additive effects on endothelial function in people with obesity and MAFLD, in addition to improving metabolic, lipid and hepatic steatosis profile. the researcher´s aim is to evaluate the effect of citrulline and HIIT on arterial stiffness assessed by PWV in adolescents with MAFLD. For this the investigators will perform a randomized, double-blind clinical study in 45 adolescents with MAFLD and obesity, who will be supplemented with 6 g per day with L-citrulline or placebo (Carboxymethylcellulose) and will perform HIIT sessions for 12 weeks. At the beginning and at the end of the intervention, the level of arterial stiffness by means of PWV, body composition, biochemical and metabolic data, as well as the degree of hepatic steatosis will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05778266
Study type	Interventional
Source	Universidad de Guanajuato
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	March 14, 2023
Completion date	August 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of L-citrulline and HIIT on Arterial Stiffness and MAFLD in Adolescents

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms