Clinical trial NCT05778266: Effect of L-citrulline and HIIT on Arterial Stiffness, Body Composition, and Lipid Profile in Adolescents with Steatosis Associated with Metabolic Dysfunction (MASLD)
Official title: Effect of L-citrulline and HIIT on Arterial Stiffness, Body Composition, and Lipid Profile in Adolescents with Steatosis Associated with Metabolic Dysfunction (MASLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Dysfunction-Associated Fatty Liver Disease
Obesity, Adolescent
Arterial Stiffness
Keywords: MAFLD
Obesity
Adolescents
PWV
AIx75
HIIT
L-citrulline supplementation
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 43
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An intervention with exercise in modality of High-Intensity Interval Training (HIIT) and Oral administration of L-citrulline (L-cit) or placebo (Pl) as follows:

Group L-cit + HIIT: capsules of 6 g of citrulline will be supplemented per day, distributed as 3 g (4 capsules) in the morning before the first meal and 3 g in the evening before sleep for a period of 12 weeks. The sessions of HIIT will be made 3 days per week in a stationary bicycle Group Pl + HIIT: Carboxymethyl cellulose will be used as placebo. 4 capsules will be taken in the morning before the first meal and 4 capsules at night before going to sleep for a period of 12 weeks. The sessions of HIIT will be made 3 days per week in a stationary bicycle.

Group L-cit without HIIT: capsules of citrulline will be supplemented per day, distributed as 3 g (4 capsules) in the morning before the first meal and 3 g (4 capsules) in the evening before sleep for a period of 12 weeks. This group will not made exercise.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 12 weeks
measure: Reflected Wave
timeFrame: 12 weeks
measure: Degree of hepatic steatosis
timeFrame: 12 weeks
Secondary outcomes:
measure: Glucose metabolism: glucose
timeFrame: 12 weeks
measure: Glycated hemoglobin (HbA1c)
timeFrame: 12 weeks
measure: Insuline Resistance
timeFrame: 12 weeks
measure: Lipid profile
timeFrame: 12 weeks
measure: VO2max
timeFrame: 12 weeks
measure: Arterial Pressure
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: León
country: Mexico
facility: Universidad de Guanajuato
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Ma. Eugenia Garay-Sevilla, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Guanajuato
name: Alan Arturo Rodriguez-Carrillo, Bachelor
role: STUDY_CHAIR
References: