NCT05124847已完成不适用
Time Restricted Eating as a Treatment for Pediatric Obesity
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Carotid intima-media thickness
研究概览
简要总结
The main aim of the study is to collect preliminary information on the feasibility and efficacy of a time restricted eating intervention in Spanish children and adolescents with obesity and metabolic comorbidities. Two 8-week interventions will performed in a randomized crossover controlled design: a) reduction of the habitual eating window; b) standard care. Different measurements of body composition and cardiometabolic health markers will be performed along those weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 10 and 15 at the start of the study.
- •Obesity defined according to the criteria of the World Health Organization (BMI≥p95) and at least one of the following conditions:
- •Hepatic steatosis confirmed by abdominal ultrasound in the previous 12 months.
- •Triglycerides> 150 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.
- •HDL cholesterol <40 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.
- •LDL cholesterol> 135 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.
- •Insulin resistance, determined by elevated HOMA-IR confirmed by analytical determination in the 4 weeks prior to the start of the study.
- •Habitual eating window equal to or greater than 13 hours, with a response rate greater than 85%. Habitual eating window will be determined by self-registration during the screening process. Participants must properly record the habitual eating window in at least 12 of the 14 days that self-registration will be requested, and it must be equal to or greather than 13 hours at least 6 days a week.
- •Reporting to have maintained a stable weight and height status during the last two months (changes of less than 2 points in BMI (kg / m2)).
- •Agreement to participate in all phases and procedures of the study.
排除标准
- •Being diagnosed with an endocrine disorder, for example, diabetes mellitus under treatment with insulin or oral antidiabetics, thyroid disease, hypercortisolism, congenital adrenal hyperplasia.
- •Being diagnosed with a chronic digestive, rheumatological, neurological, cardiological, pneumological, autoimmune or infectious disease that affects energy metabolism.
- •Having undergone a surgical procedure that chronically alternates digestive or metabolic function.
- •Hypercholesterolemia requiring pharmacological treatment according to the Expert Consensus of the European Society of Arteriosclerosis specific to children.
- •Serum triglyceride concentration> 500 mg/dl.
- •Systolic or diastolic blood pressure values equal to or greater than the specific 95th percentile for age, sixth, and height, on 3 different occasions [42].
- •Hypertransaminasemia> 200 IU / L (5 times higher than the upper normal value in the laboratory), which would make it necessary to rule out other causes of liver disease.
- •Being diagnosed with an eating disorder or being at risk of developing these disorders, determined using the SCOFF questionnaire (two or more questions answered positively).
- •Presenting neurological alterations or chromosomopathies.
- •Consuming drugs or supplements that are likely to alter energy metabolism.
- •Being participating in a nutritional intervention or treatment of any kind, or having done so during the previous 3 months.
- •Having a demonstrable personal or professional relationship with any of the members of the investigation team.
- •Any other condition that in the opinion of the research team would contraindicate their participation.
结局指标
主要结局
Carotid intima-media thickness
时间窗: week 8
Continuous glucose monitoring
时间窗: From week 6 to week 8
Body weight
时间窗: week 8
Hepatic steatosis
时间窗: week 8
Length of eating window
时间窗: From week 0 to week 8
Body fat mass
时间窗: week 8
HOMA-IR
时间窗: week 8
Lipid profile
时间窗: week 8
次要结局
未报告次要终点
研究者
研究点 (2)
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