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

Not Applicable

Completed

• Conditions: Obesity, Adolescent; Arterial Stiffness; Metabolic Dysfunction-Associated Fatty Liver Disease
• Interventions: Dietary Supplement: L-citrulline; Dietary Supplement: Carboxymethyl cellulose; Other: High Intensity Intervals Training

• Registration Number: NCT05778266
• Lead Sponsor: Universidad de Guanajuato

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-02-19
• Status Verified: 2023-03
• Study Start: 2023-03-14
• Study First Submitted QC: 2023-03-18
• Study First Posted: 2023-03-21
• Primary Completion: 2024-01-15
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Cit	L-citrulline	adolescents will be supplemented with 6 g/day of L-citrulline but without do exercise for 12 weeks
L-Cit + HIIT	High Intensity Intervals Training	adolescents will be supplemented with 6 g/day of L-citrulline and 3 sessions per week of HIIT for 12 weeks
Placebo + HIIT	Carboxymethyl cellulose	adolescents will be supplemented with 6 g/day of Carboxymethyl cellulose and 3 sessions per week of HIIT for 12 weeks
L-Cit + HIIT	L-citrulline	adolescents will be supplemented with 6 g/day of L-citrulline and 3 sessions per week of HIIT for 12 weeks
Placebo + HIIT	High Intensity Intervals Training	adolescents will be supplemented with 6 g/day of Carboxymethyl cellulose and 3 sessions per week of HIIT for 12 weeks

Primary Outcome Measures

Name	Time	Method
Arterial Stiffness	12 weeks	The degree of arterial stiffness will be evaluated by oscillometric device (Mobil-O Graph). This device assesses Pulse Wave Velocity
Reflected Wave	12 weeks	The Augmentation Index (AIx) measures the percentage of the pressure increase that is caused by the premature arrival of the reflected wave and is expressed as the ratio of PAo and PP multiplied by 100. AIx@75 is AIx corrected to a heart rate of 75 beats per minute. The Mobil-O Graph device also evaluates AIx@75
Degree of hepatic steatosis	12 weeks	The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as: 1. Moderate, when sound attenuation is added.; 2. Severe, when the wall of the portal vessels and the diaphragm are not visible.

Secondary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c)	12 weeks	Glycated hemoglobin (HbA1c) will be measured by reflectance spectrophotometry, by boronic acid affinity.
Arterial Pressure	12 weeks	Is pressure exerted by the blood on the artery wall. The mobil-O Graph also evaluates arterial pressure and reports it as Dyastolic Pressure (DAP), Systolic Pressure (SAP) and Mean Arterial Pressure (MAP)
Glucose metabolism: glucose	12 weeks	Glucose will be evaluated by the Lakeside glucose oxidase method (GOD-PAPTM).
Insuline Resistance	12 weeks	Insulin level will be measured by ELISA (ALPCO) method. The Homeostatic Model Assessment Index (HOMA-IR) will be calculated to determine insulin resistance.
Lipid profile	12 weeks	The lipid profile will be measured by the modified Huang method.
VO2max	12 weeks	VO2max is a measure of aerobic exercise capacity. It will be performed on a cycloergometer. Every 2 minutes 0.5 kp will be increased and HR will be measured minute by minute with a portable monitor (Polar HO1). When the participant no longer maintains the 60 rpm cadence or reaches the maximum perceived exertion on the modified Borg scale (9 or 10), the test is terminated.
Body composition	12 weeks	Bioelectrical impedance will be used to assess total body composition as fat free mass (FFM), fat mass (FM) and total body water, using the standard configuration.; The portable, multi-frequency In body S10 device will be used and it reports body composition in percentage (%)

Trial Locations

Locations (1)

Universidad de Guanajuato; 🇲🇽 León, Guanajuato, Mexico