Target Mitochondrial Fitness, Chronobiology and Metabolism

Study Overview
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Brief Summary
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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: - 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). - To study mitochondria fitness under morning or afternoon aerobic and anaerobic exercise (prospective study: basal, 4, 8 and 12 weeks of the study). - 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). - 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. - 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).

Official Title
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Target Mitochondrial Fitness, Chronobiology and Metabolism

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Aerobic or anaerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20- IMC <30 kg/m2 Informed consent Exclusion Criteria: Smoker Previous physical exercise of more than 20 minutes / 2 times a week

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise arm<br>Subjects perfom aerobic or anaerobic exercise in the morning or in the afternoon | Other: Aerobic or anaerobic exercise<br>* Aerobic or anaerobic exercise in the morning or in the afternoon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Weight in kg | From baseline to week 12 | 
| BMI (body mass index) changes | Measured by body composition analysis | From baseline to week 12 | 
| Change in waist circumference | Circumference in cm | From baseline to week 12 | 
| Change in hip circumference | Circumference in cm | From baseline to week 12 | 
| Changes in diastolic and systolic blood pressure | To analyze the effect of exercise on blood pressure | From baseline to week 12 | 
| Changes in body composition | To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis | From baseline to week 12 | 
| Change in glucose concentration | Glucose in mg/dl | From baseline to week 12 | 
| Change in insulin concentration | Insulin in mg/dl | From baseline to week 12 | 
| Change in glycated haemoglobin concentration | Glycated haemoglobin in mg/dl | From baseline to week 12 | 
| Change in Triglycerides concentration | Triglycerides in mg/dl | From baseline to week 12 | 
| Change in cholesterol concentration | Serum cholesterol in mg/dl | From baseline to week 12 | 
| Change in HDL concentration | Serum HDL in mg/dl | From baseline to week 12 | 
| Change in LDL concentration | Serum LDL in mg/dl | From baseline to week 12 | 
| Change in transaminases concentration | Serum transaminases in UI/l | From baseline to week 12 | 
| Change in creatinine concentration | Creatinine in mg/dl | From baseline to week 12 | 
| Change in uric acid concentration | Uric acid in mg/dl | From baseline to week 12 | 
| Change in alkaline phosphatase concentration | Serum alkaline phosphatase in UI/l | From baseline to week 12 | 
| Change in bilirubin concentration | Serum bilirubin in mg/dl | From baseline to week 12 | 
| Change in lactate concentration | Serum lactate in mmol/L | From baseline to week 12 | 
| Change in cortisol concentration | Serum cortisol in nmol/L | From baseline to week 12 | 
| Change in total and free testosterone concentration | Serum total and free testosterone in nmol/L | From baseline to week 12 | 
| Change in melatonine concentration | Serum melatonine in pg/ml | From baseline to week 12 | 
| Characterize exercise participant behavior | 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. | From baseline to week 12 | 
| Mediterranean diet adherence questionnaire | 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. | From baseline to week 12 | 
| Change in faecal microbiota | 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 | From baseline to week 12 | 
| Change in fitness mitochondrial | 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. | From baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitochondrial fitness, Metabolism, Chronobiology