The Effect of Time-Restricted Feeding on Body Composition and Some Metabolic Parameters in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in body weight
研究概览
简要总结
Obesity is now recognized as a serious public health problem. It is known that obesity seen in adolescence is largely carried over to adulthood. Therefore, its treatment is important both in terms of protecting current health and preventing diseases in adulthood. Reducing energy intake plays an important role in the treatment of obesity. However, long-term adherence and effectiveness to energy restriction appear to be limited. Therefore, the need for interventions that are "effective in body weight loss" and "accessible, simple and lifestyle modification to increase dietary compliance" is clear. Time-restricted feeding is a specialized intermittent fasting protocol that includes consistent fasting and eating periods over a 24-hour cycle by supporting circadian rhythms. Especially in the adult population, positive effects of time-restricted feeding such as weight loss and blood glucose regulation are observed. However, there are limited data on this subject for adolescents. Today, the Mediterranean diet, which is one of the nutrition models that supports health, is a beneficial nutritional model that reduces body weight and obesity-related comorbidities by limiting total energy intake. However, no study has been found in the literature in which the effectiveness of time-restricted nutrition, which is a new and promising approach, and the Mediterranean diet, which is a sustainable diet model, are evaluated together. Therefore, in this study, it was aimed to evaluate the effects of planned time-restricted nutrition compatible with circadian rhythm and energy-restricted feeding planned according to the Mediterranean diet model on body composition and various metabolic parameters in obese adolescents. 60 obese adolescents aged 12-18 years will be included in this randomized controlled and parallel design study. Participants will be randomized to one of two treatment groups for a 12-week intervention. The time-restricted feeding group will form the intervention group of the study, and the energy-restricted feeding group will form the control group. Anthropometric measurements of the participants at the beginning and end of the study will be taken, and various biochemical parameters will be evaluated with the body composition and blood samples to be taken. As a result of the study, it is expected to determine the effectiveness of time-restricted feeding compared to energy-restricted feeding in terms of dietary compliance, body composition and biochemical changes.
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
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 12-18 with puberty stage:5
- •Obese adolescents with a metabolic disorder (such as fatty liver, insulin resistance, prediabetes, dyslipidemia) (BMI≥95th percentile for age)
- •Those who have a stable body weight for 3 months before the start of the study (current weight gain or loss <4 kg)
- •Those who own and can use a Smartphone with Apple iOS or Android operating system
- •Those who speak, read and understand Turkish
排除标准
- •Those with any endocrine disorder, metabolic, chronic or major psychiatric disease other than obesity, insulin resistance, dyslipidemia, prediabetes, fatty liver
- •Polycystic ovary syndrome (PCOS)
- •Those with physical or mental disabilities
- •Those with allergies, intolerances or eating disorders
- •Those who smoke and drink alcohol
- •Use of drugs that may affect study results, circadian rhythms or metabolism (such as antidiabetics, steroids, beta blockers, adrenergic stimulating agents, laxatives, etc.)
结局指标
主要结局
Changes in body weight
时间窗: Baseline, Week 4, Week 8 and Week 12
Changes in body weight will be examined as a result of the implemented nutrition plan.
Changes in body fat percentage
时间窗: Baseline, Week 4, Week 8 and Week 12
Changes in body fat percentage as a result of the implemented nutrition plan will be examined. The fat percentage will be assessed based on measurements taken with bioimpedance analysis devices.
Changes in body mass index
时间窗: Baseline, Week 4, Week 8 and Week 12
Changes in body mass index as a result of the implemented nutrition plan will be examined. Body mass index (BMI) will be calculated based on changes in height (cm) and weight (kg) values, using the formula kg/m².
Biochemical changes
时间窗: Baseline and Week 12
As a result of the implemented nutrition plan, changes in fasting glucose (mg/dL), total cholesterol (mg/dL), LDL cholesterol (LDL-C; mg/dL), HDL cholesterol (HDL-C; mg/dL), and triglycerides (mg/dL) levels will be evaluated.
Changes in glycated hemoglobin levels
时间窗: Baseline and Week 12
As a result of the implemented nutrition plan, changes in glycated hemoglobin (HbA1c) levels will be evaluated.
Changes in insulin levels
时间窗: Baseline and Week 12
As a result of the implemented nutrition plan, changes in insulin levels (measured in µIU/mL) will be evaluated.
Changes in hormone levels
时间窗: Baseline and Week 12
At the conclusion of the implemented nutrition plan, changes in the levels of leptin, ghrelin, adiponectin, irisin, and nesfatin hormones (ng/mL) will be evaluated.
Changes in inflammatory markers
时间窗: Baseline and Week 12
At the conclusion of the implemented nutrition plan, changes in various inflammation markers, including interleukin (IL)-17, IL-10, IL-6, IL-1β, and TNF-α (ng/mL), will be evaluated.
次要结局
未报告次要终点
研究者
Sümeyra Başar
project manager
TC Erciyes University