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

NCT05778266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Universidad de Guanajuato

    lead OTHER

Principal Investigators

  • Ma. Eugenia Garay-Sevilla, PhD · Universidad de Guanajuato

  • Alan Arturo Rodriguez-Carrillo, Bachelor · Universidad de Guanajuato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2024-01-15
Completion
2024-04-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05778266 on ClinicalTrials.gov