Effect of L-citrulline and HIIT on Arterial Stiffness, Body Composition, and Lipid Profile in Adolescents with Steatosis Associated with Metabolic Dysfunction (MASLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Arterial Stiffness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Arterial Stiffness
时间窗: 12 weeks
The degree of arterial stiffness will be evaluated by oscillometric device (Mobil-O Graph). This device assesses Pulse Wave Velocity
Reflected Wave
时间窗: 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
时间窗: 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.
次要结局
- Glycated hemoglobin (HbA1c)(12 weeks)
- Arterial Pressure(12 weeks)
- Glucose metabolism: glucose(12 weeks)
- Insuline Resistance(12 weeks)
- Lipid profile(12 weeks)
- VO2max(12 weeks)
- Body composition(12 weeks)
研究者
Ma Eugenia Garay Sevilla
Titular Research Professor
Universidad de Guanajuato