NCT05778266

Effect of L-citrulline and HIIT on Arterial Stiffness, Body Composition, and Lipid Profile in Adolescents with Steatosis Associated with Metabolic Dysfunction (MASLD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Universidad de Guanajuato · Academic / Other
• Sex: All
• Age: 15 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

Obesity and metabolic dysfunction-associated steatotic liver disease (MASLD) 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 MASLD. High intensity interval training (HIIT) has also shown benefits on endothelial function improving the metabolic profile of people with obesity and MASLD 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 MASLD and the participants will be divided into 3 groups to perform HIIT and supplement with citrulline or placebo for 12 weeks.

Detailed description

The investigators hypothesize that citrulline and HIIT have additive effects on endothelial function in people with obesity and MASLD, 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 MASLD. For this the investigators will perform a randomized, double-blind clinical study in 45 adolescents with MASLD 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.

Conditions

• Metabolic Dysfunction-Associated Fatty Liver Disease
• Obesity, Adolescent
• Arterial Stiffness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-citrulline	oral supplementation of pure L-citrulline (6 g) for twelve weeks
DIETARY_SUPPLEMENT	Carboxymethyl cellulose	oral supplementation of Carboxymethyl cellulose (6 g) as a placebo, for twelve weeks
OTHER	High Intensity Intervals Training	participants will have sessions 3 days a week for twelve weeks

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-01-15
• Completion: 2024-04-30
• First posted: 2023-03-21
• Last updated: 2024-12-20

Locations

1 site across 1 country: Mexico