MedDataX Logo

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

NCT ID: NCT05778266

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

MAFLD Obesity Adolescents PWV AIx75 HIIT L-citrulline supplementation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The selection of which group each adolescent will belong to, will be made by randomization by computer numbers by a researcher from the department of medical sciences of the University of Guanajuato, who is not involved in treatment and follow-up. The researcher will designated into a placebo or L-cit group. The investigator and the participants will not know the group which they belong.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

L-Cit + HIIT

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

Group Type ACTIVE_COMPARATOR

L-citrulline

Intervention Type DIETARY_SUPPLEMENT

oral supplementation of pure L-citrulline (6 g) for twelve weeks

High Intensity Intervals Training

Intervention Type OTHER

participants will have sessions 3 days a week for twelve weeks

L-Cit

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

Group Type ACTIVE_COMPARATOR

L-citrulline

Intervention Type DIETARY_SUPPLEMENT

oral supplementation of pure L-citrulline (6 g) for twelve weeks

Placebo + HIIT

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

Group Type PLACEBO_COMPARATOR

Carboxymethyl cellulose

Intervention Type DIETARY_SUPPLEMENT

oral supplementation of Carboxymethyl cellulose (6 g) as a placebo, for twelve weeks

High Intensity Intervals Training

Intervention Type OTHER

participants will have sessions 3 days a week for twelve weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

L-citrulline

oral supplementation of pure L-citrulline (6 g) for twelve weeks

Intervention Type DIETARY_SUPPLEMENT

Carboxymethyl cellulose

oral supplementation of Carboxymethyl cellulose (6 g) as a placebo, for twelve weeks

Intervention Type DIETARY_SUPPLEMENT

High Intensity Intervals Training

participants will have sessions 3 days a week for twelve weeks

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo HIIT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Guanajuato

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ma Eugenia Garay Sevilla

Titular Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ma. Eugenia Garay-Sevilla, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Guanajuato

Alan Arturo Rodriguez-Carrillo, Bachelor

Role: STUDY_CHAIR

Universidad de Guanajuato

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad de Guanajuato

León, Guanajuato, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

References

Explore related publications, articles, or registry entries linked to this study.

Rodriguez-Carrillo AA, Espinoza-Vargas MR, Vargas-Ortiz K, Ibarra-Reynoso LDR, Olvera-Juarez M, Gomez-Ojeda A, Garay-Sevilla ME, Figueroa A. Impact of L-Citrulline Supplementation and HIIT on Lipid Profile, Arterial Stiffness, and Fat Mass in Obese Adolescents with Metabolic-Dysfunction-Associated Fatty Liver Disease: A Randomized Clinical Trial. Nutrients. 2025 Jan 23;17(3):402. doi: 10.3390/nu17030402.

Reference Type DERIVED
PMID: 39940261 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PWV-MAFLD-HIIT-CITRULLINE

Identifier Type: -

Identifier Source: org_study_id