NCT05778266Completed
Effect of L-citrulline and HIIT on Arterial Stiffness, Body Composition, and Lipid Profile in Adolescents with Steatosis Associated with Metabolic Dysfunction (MASLD)
Source: ClinicalTrials.gov · Last updated 20 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 19 Feb 2023
- Start date
- 14 Mar 2023
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- Universidad de Guanajuato
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05778266
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 14 Mar 2023 to the primary completion date, 15 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants who present allergy or intolerance to L-citrulline.
Other
- 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 any injury during the intervention period that prevents them from performing the training.
Who the study is looking for
- 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
Age in the registry: 15 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Guanajuato Coordinator of this site? Confirm its status | León | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.