Evaluation of Molecular Hydrogen Supplementation to Enhance the Efficacy of Weight Loss Retreat in Overweight and Obese Adolescents. A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body mass index
研究概览
简要总结
This randomized controlled trial evaluates whether molecular hydrogen supplementation enhances the effectiveness of a 4-week weight loss retreat in overweight and obese adolescents. Outcome measures include: body composition, physical status, blood samples (insulin sensitivity, lipid profiles, markers of oxidative stress and inflammation) and autonomic nervous system function.
详细描述
The aim of this randomized, double-blind, parallel-group, placebo-controlled trial is to evaluate whether molecular hydrogen supplementation enhances the effectiveness of weight loss retreat for overweight and obese adolescents. Weight loss retreat is indicated for participants based on diagnosis and recommendation of a pediatrician. During the 4-week retreat, participants follow a prescribed standardized intervention consisting of reduction diet and physical activity. The total planned number of participants is 60. Participants are randomly divided into two balanced groups, with one group receiving molecular hydrogen in the form of hydrogen-rich water and the other receiving a placebo water. The daily amount of water given (hydrogen-rich or placebo) is 1.5 L. Hydrogen-rich water is packaged in specially designed aluminum containers to minimize hydrogen leakage and ensure long-term stability with a dissolved hydrogen concentration of 1.2-1.6 ppm. Participants are unable to distinguish hydrogen-rich water from the placebo because molecular hydrogen is colorless, odorless, and tasteless. Participants monitor their physical activity, sleep, and sedentary behavior one week before to retreat and undergo baseline diagnostics (including blood sampling), three weekly interim diagnostics during retreat, and final diagnostics (including blood sampling) after four weeks. If participants are available, two follow-up diagnostics are conducted six weeks and six months after the retreat and include seven-day monitoring of physical activity, sleep, and sedentary behavior. Statistical analysis is performed at a significance level of α = 0.05 and the data is evaluated using analysis of variance. In cases of non-normality, data transformations or non-parametric alternatives are used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index indicating overweight or obesity, as determined according to the World Health Organization's international percentile charts for children aged 5-19 years.
- •Presence of a regular menstrual cycle in female participants.
- •Signed informed consent from the legal representative.
排除标准
- •High blood pressure.
- •Dyslipoproteinemia.
- •Cardio-respiratory disorders.
- •Musculoskeletal disorders.
- •Use of any medications regulating heart rhythm or the neurovegetative and hormonal system.
研究组 & 干预措施
Molecular hydrogen
Supplementation with molecular hydrogen in the form of hydrogen-rich water administered 1.5 L per day - before breakfast (500 ml), lunch (500 ml) and dinner (500 ml).
干预措施: Hydrogen-rich water (Dietary Supplement)
Placebo
Supplementation with drinking water administered 1.5 L per day - before breakfast (500 ml), lunch (500 ml) and dinner (500 ml).
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Body mass index
时间窗: Baseline and 4 weeks
Body mass index is calculated as the ratio of body mass (kg) to the square of body height (m2). Body mass is measured using a digital scale to the nearest 0.1 kg and body height is measured using a stadiometer to the nearest 1 cm.
Six-minute walk test
时间窗: Baseline and 4 weeks
Six-minute walk test is measured by recording the total distance the participant is able to walk on a flat surface within six minutes. The participant is instructed to walk at his/her own pace in order to walk as far as possible in the given time.
次要结局
- Body fat(Baseline and 4 weeks)
- High-density lipoprotein(Baseline and 4 weeks)
- 30-second sit-to-stand test(Baseline and 4 weeks)
- Maximal isometric grip force(Baseline and 4 weeks)
- Maximal wall sit(Baseline and 4 weeks)
- Resting blood lactate(Baseline and 4 weeks)
- Homeostatic model assessment of insulin resistance(Baseline and 4 weeks)
- Total cholesterol(Baseline and 4 weeks)
- Low-density lipoprotein(Baseline and 4 weeks)
- Triglycerides(Baseline and 4 weeks)
- Cortisol(Baseline and 4 weeks)
- Fibroblast growth factor 21(Baseline and 4 weeks)
- Total antioxidant capacity(Baseline and 4 weeks)
- Malondialdehydes(Baseline and 4 weeks)
- Protein carbonyls(Baseline and 4 weeks)
- Interleukin-6(Baseline and 4 weeks)
- Tumor necrosis factor alpha(Baseline and 4 weeks)
研究者
Jakub Krejci
Assistant professor
Palacky University