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

Universidad de Guanajuato

Status: Completed

Conditions: Obesity, Adolescent; Metabolic Dysfunction-Associated Fatty Liver Disease; Arterial Stiffness

Treatments: Dietary Supplement: L-citrulline; Other: High Intensity Intervals Training; Dietary Supplement: Carboxymethyl cellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT05778266

PWV-MAFLD-HIIT-CITRULLINE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 15 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of obesity and metabolic associated-dysfunction steatotic liver disease associated with (MASLD) and with moderate or severe steatosis
• History of physical inactivity
• They should not be under treatment with any dietary supplement or polyvitamins for weight loss at least 6 months before the study.
• They should not be smokers.
• Not have a diagnosis of any chronic degenerative disease
• Adolescents without fracture or musculoskeletal injury
• Patients without surgical procedures at least 1 month prior to the protocol.
• Women who are not pregnant or use oral contraceptives

Exclusion criteria

• Participants who do not complete at least 80% of the training sessions.
• Participants who miss 2 consecutive weeks of training.
• Who do not ingest the L-citrulline supplement or placebo.
• Participants who present allergy or intolerance to L-citrulline.
• Participants who present any injury during the intervention period that prevents them from performing the training.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 3 patient groups, including a placebo group

L-Cit + HIIT

Active Comparator group

Description:

adolescents will be supplemented with 6 g/day of L-citrulline and 3 sessions per week of HIIT for 12 weeks

Treatment:

Other: High Intensity Intervals Training

Dietary Supplement: L-citrulline

L-Cit

Active Comparator group

Description:

adolescents will be supplemented with 6 g/day of L-citrulline but without do exercise for 12 weeks

Treatment:

Dietary Supplement: L-citrulline

Placebo + HIIT

Placebo Comparator group

Description:

adolescents will be supplemented with 6 g/day of Carboxymethyl cellulose and 3 sessions per week of HIIT for 12 weeks

Treatment:

Dietary Supplement: Carboxymethyl cellulose

Other: High Intensity Intervals Training