Effect of Melatonin on Oxidative Stress in Obese Adults Undergoing an Acute Exercise Session
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- dROMS (reactive oxygen species) during physical exercise protocol
研究概览
简要总结
The present research project aims to evaluate oxidative stress in a cohort of obese adults, subjected to an in-hospital 3-week multidisciplinary body weight reduction program (BWRP) with or without melatonin. Our hypothesis is that melatonin, administered to the obese subject, could be effective in reducing the oxidative stress associated with physical exercise (acute).
Specifically, the main objective will be to investigate a difference in the mean levels of some peripheral oxidative stress markers at their peak during an acute exercise session in the two groups (primary endpoint).
Secondly, the possible pre-post difference (baseline vs end of treatment) of the peak of each oxidative stress marker between the two groups will be evaluated (secondary endpoint
详细描述
Materials and methods 20 obese subjects (F/M = 10/10; age range 18-40 years; body mass index, BMI > 30 kg/m2), hospitalized for a period of integrated metabolic rehabilitation (BWRP) at the Division of Metabolic Diseases, Istituto Auxologico Italiano, Piancavallo (VB), Italy.
After verifying the inclusion/exclusion criteria, including the absence of other relevant pathologies apart from obesity, we will proceed with the collection of clinical data (heart rate, blood pressure, body temperature) and anthropometric data (weight, height, BMI, waist circumference, hip circumference), including assessment of body composition with bio-impedancemetry.
According to a randomized scheme, with the only constraint of maintaining a 1/1 ratio for sex, the subjects will undergo one of the following interventions:
- Integrated multidisciplinary BWRP, which includes a low-calorie diet, physical activity, psychological support, and nutritional education;
- Integrated multidisciplinary BWRP (as above) combined with melatonin. Melatonin will be administered during 15 consecutive days of our standard BWRP, after dinner, and 2-3 hours before bedtime. The first dose will be administered on the same evening of the day in which the incremental exercise (test 1, baseline G0) will be performed, necessary to establish the execution conditions of test 2.
The acute exercise session (test 2, described below) will be performed at D1 and D15 (days 1-15 of BWRP).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index > 30 kg/m2
- •absence of concomitant relevant diseases, apart severe obesity
- •hospitalized for a period of integrated metabolic rehabilitation
排除标准
- •concomitant relevant diseases
研究组 & 干预措施
Integrated multidisciplinary body weight reduction program (BWRP)
干预措施: BWRP (Other)
Integrated multidisciplinary body weight reduction program (BWRP) + melatonin
干预措施: BWRP + melatonin (Other)
结局指标
主要结局
dROMS (reactive oxygen species) during physical exercise protocol
时间窗: Baseline (T0'), after 30 minutes of the physical exercise protocol (T30') and at T90' and T120' at day 1 and day 15 of the intervention
Change in dROMS
Malondialdehyde (MDA) during physical exercise protocol
时间窗: Baseline and after 30, 60, 90 and 120 minutes of the physical exercise protocol at day 15 of the intervention
Change in malondialdehyde
Ratio of oxidized/reduced GSH (glutathione) during physical exercise protocol
时间窗: Baseline (T0'), after 30 minutes of the physical exercise protocol (T30') and at T90' and T120' at day 1 and day 15 of the intervention
Change in ratio of oxidized/reduced GSH (glutathione)
Plasma iron-reducing capacity (FRAP) during physical exercise protocol
时间窗: Baseline (T0'), after 30 minutes of the physical exercise protocol (T30') and at T90' and T120' at day 1 and day 15 of the intervention
Change in plasma iron-reducing capacity (FRAP)
次要结局
- Melatonin concentration(Baseline (T0') and after 30 minutes of the physical exercise protocol (T30') at day 1 and day 15 of the intervention)