Target Mitochondrial Fitness, Chronobiology and Metabolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in glucose concentration
Study Overview
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:
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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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •IMC <30 kg/m2
- •Informed consent
Exclusion Criteria
- •Previous physical exercise of more than 20 minutes / 2 times a week
Outcomes
Primary Outcomes
Change in glucose concentration
Time Frame: From baseline to week 12
Glucose in mg/dl
Change in creatinine concentration
Time Frame: From baseline to week 12
Creatinine in mg/dl
Change in hip circumference
Time Frame: From baseline to week 12
Circumference in cm
Change in waist circumference
Time Frame: From baseline to week 12
Circumference in cm
Change in HDL concentration
Time Frame: From baseline to week 12
Serum HDL in mg/dl
Change in insulin concentration
Time Frame: From baseline to week 12
Insulin in mg/dl
Change in weight
Time Frame: From baseline to week 12
Weight in kg
Changes in diastolic and systolic blood pressure
Time Frame: From baseline to week 12
To analyze the effect of exercise on blood pressure
Change in glycated haemoglobin concentration
Time Frame: From baseline to week 12
Glycated haemoglobin in mg/dl
Change in cholesterol concentration
Time Frame: From baseline to week 12
Serum cholesterol in mg/dl
Change in lactate concentration
Time Frame: From baseline to week 12
Serum lactate in mmol/L
Changes in body composition
Time Frame: From baseline to week 12
To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis
Change in Triglycerides concentration
Time Frame: From baseline to week 12
Triglycerides in mg/dl
Change in alkaline phosphatase concentration
Time Frame: From baseline to week 12
Serum alkaline phosphatase in UI/l
BMI (body mass index) changes
Time Frame: From baseline to week 12
Measured by body composition analysis
Change in LDL concentration
Time Frame: From baseline to week 12
Serum LDL in mg/dl
Change in transaminases concentration
Time Frame: From baseline to week 12
Serum transaminases in UI/l
Change in bilirubin concentration
Time Frame: From baseline to week 12
Serum bilirubin in mg/dl
Change in melatonine concentration
Time Frame: From baseline to week 12
Serum melatonine in pg/ml
Characterize exercise participant behavior
Time Frame: 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
Time Frame: From baseline to week 12
Uric acid in mg/dl
Change in cortisol concentration
Time Frame: From baseline to week 12
Serum cortisol in nmol/L
Change in faecal microbiota
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From baseline to week 12
Serum total and free testosterone in nmol/L
Secondary Outcomes
No secondary outcomes reported