Target Mitochondrial Fitness, Chronobiology and Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in glucose concentration
研究概览
简要总结
Exercise could be an element that affects the biochemical, metabolic and microbiome parameters of organisms. Thus, to identify and validate the effects of aerobic and anaerobic exercises at different times of the day (morning or afternoon) on mitochondrial fitness and whether this changes could have a relation with metabolism and cardiovascular parameters and microbiome is of great interest for its applicability in biomedicine.
As specific objectives of this project will study:
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- To study the direct effect of aerobic and anaerobic exercise at different time points in the day on mitochondria fitness (short study: basal, at the end of the exercise and 2 h after exercise).
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- To study mitochondria fitness under morning or afternoon aerobic and anaerobic exercise (prospective study: basal, 4, 8 and 12 weeks of the study).
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- To identify and validate modulators and target proteins of mitochondria fitness affected by exercise (miRNA omic and proteomic analysis of mitochondria from the different groups of the study at basal and 12 weeks of the study).
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- To study the relationship of the mitochondrial response (Objectives 1 and 2) to the different combination of exercises and chronobiology with anthropometric-clinical, carbohydrate and lipid metabolic and cardiovascular changes.
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- To check the effect of morning or afternoon aerobic and anaerobic exercise on gut microbiota and its relation to mitochondria fitness, clinical and metabolic parameters (basal, 4, 8 and 12 weeks of the study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IMC <30 kg/m2
- •Informed consent
排除标准
- •Previous physical exercise of more than 20 minutes / 2 times a week
结局指标
主要结局
Change in glucose concentration
时间窗: From baseline to week 12
Glucose in mg/dl
Change in creatinine concentration
时间窗: From baseline to week 12
Creatinine in mg/dl
Change in hip circumference
时间窗: From baseline to week 12
Circumference in cm
Change in waist circumference
时间窗: From baseline to week 12
Circumference in cm
Change in HDL concentration
时间窗: From baseline to week 12
Serum HDL in mg/dl
Change in insulin concentration
时间窗: From baseline to week 12
Insulin in mg/dl
Change in weight
时间窗: From baseline to week 12
Weight in kg
Changes in diastolic and systolic blood pressure
时间窗: From baseline to week 12
To analyze the effect of exercise on blood pressure
Change in glycated haemoglobin concentration
时间窗: From baseline to week 12
Glycated haemoglobin in mg/dl
Change in cholesterol concentration
时间窗: From baseline to week 12
Serum cholesterol in mg/dl
Change in lactate concentration
时间窗: From baseline to week 12
Serum lactate in mmol/L
Changes in body composition
时间窗: From baseline to week 12
To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis
Change in Triglycerides concentration
时间窗: From baseline to week 12
Triglycerides in mg/dl
Change in alkaline phosphatase concentration
时间窗: From baseline to week 12
Serum alkaline phosphatase in UI/l
BMI (body mass index) changes
时间窗: From baseline to week 12
Measured by body composition analysis
Change in LDL concentration
时间窗: From baseline to week 12
Serum LDL in mg/dl
Change in transaminases concentration
时间窗: From baseline to week 12
Serum transaminases in UI/l
Change in bilirubin concentration
时间窗: From baseline to week 12
Serum bilirubin in mg/dl
Change in melatonine concentration
时间窗: From baseline to week 12
Serum melatonine in pg/ml
Characterize exercise participant behavior
时间窗: From baseline to week 12
International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) carried out in the last seven days, as well as walking and sitting time in a work day. It evaluates three characteristics of physics (PA): intensity (mild, moderate or vigorous), frequency (days per week) and duration (time per day). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Index Units) per minute and week.
Change in uric acid concentration
时间窗: From baseline to week 12
Uric acid in mg/dl
Change in cortisol concentration
时间窗: From baseline to week 12
Serum cortisol in nmol/L
Change in faecal microbiota
时间窗: From baseline to week 12
To evaluate faecal microbiota composition in the studied subjects and the effect of aerobic and anaerobic exercise in the morning or afternoon on faecal microbiota composition. 16S rRNA amplicons of fecal community DNA
Change in fitness mitochondrial
时间窗: From baseline to week 12
To evaluate the effect of aerobic and anaerobic exercise in the morning or afternoon on mitochondrial fitness, evaluated by mitochondrial gene expression and protein abundance, mitochondrial metabolites, mitochondrial markers trough flow citometry.
Mediterranean diet adherence questionnaire
时间窗: From baseline to week 12
To evaluate adherence to a Mediterranean diet pattern. It consists of 14 items in which different components of the Mediterranean diet are evaluated (number of pieces of fruit consumed per day, number of portions of legumes consumed per week...). Each item is scored as 0 or 1. A total score of \<9 indicates poor adherence, while a score of ≥9 indicates good adherence.
Change in total and free testosterone concentration
时间窗: From baseline to week 12
Serum total and free testosterone in nmol/L
次要结局
未报告次要终点