Target Mitochondrial Fitness, Chronobiology and Metabolism
- Conditions
- Healthy Subjects
- Interventions
- Other: Aerobic or anaerobic exercise
- Registration Number
- NCT05600192
- Lead Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Brief Summary
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:
1. - 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).
2. - To study mitochondria fitness under morning or afternoon aerobic and anaerobic exercise (prospective study: basal, 4, 8 and 12 weeks of the study).
3. - 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).
4. - 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.
5. - 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 20-
- IMC <30 kg/m2
- Informed consent
- Smoker
- Previous physical exercise of more than 20 minutes / 2 times a week
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise arm Aerobic or anaerobic exercise Subjects perfom aerobic or anaerobic exercise in the morning or in the afternoon
- Primary Outcome Measures
Name Time Method Change in waist circumference From baseline to week 12 Circumference in cm
Change in HDL concentration From baseline to week 12 Serum HDL in mg/dl
Change in creatinine concentration From baseline to week 12 Creatinine in mg/dl
Change in hip circumference From baseline to week 12 Circumference in cm
Change in weight From baseline to week 12 Weight in kg
Changes in diastolic and systolic blood pressure From baseline to week 12 To analyze the effect of exercise on blood pressure
Change in insulin concentration From baseline to week 12 Insulin in mg/dl
Change in glycated haemoglobin concentration From baseline to week 12 Glycated haemoglobin in mg/dl
Change in cholesterol concentration From baseline to week 12 Serum cholesterol in mg/dl
Change in lactate concentration From baseline to week 12 Serum lactate in mmol/L
Changes in body composition From baseline to week 12 To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis
Change in Triglycerides concentration From baseline to week 12 Triglycerides in mg/dl
Change in alkaline phosphatase concentration From baseline to week 12 Serum alkaline phosphatase in UI/l
BMI (body mass index) changes From baseline to week 12 Measured by body composition analysis
Change in LDL concentration From baseline to week 12 Serum LDL in mg/dl
Change in transaminases concentration From baseline to week 12 Serum transaminases in UI/l
Change in bilirubin concentration From baseline to week 12 Serum bilirubin in mg/dl
Change in melatonine concentration From baseline to week 12 Serum melatonine in pg/ml
Characterize exercise participant behavior 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 From baseline to week 12 Uric acid in mg/dl
Change in cortisol concentration From baseline to week 12 Serum cortisol in nmol/L
Change in faecal microbiota 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 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 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 From baseline to week 12 Serum total and free testosterone in nmol/L
Change in glucose concentration From baseline to week 12 Glucose in mg/dl
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain