Clinical trial NCT05600192: Target Mitochondrial Fitness, Chronobiology and Metabolism
Official title: Target Mitochondrial Fitness, Chronobiology and Metabolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Keywords: Mitochondrial fitness
Metabolism
Chronobiology
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: Inclusion Criteria:

* 20-
* IMC \<30 kg/m2
* Informed consent

Exclusion Criteria:

* Smoker
* Previous physical exercise of more than 20 minutes / 2 times a week

Primary outcomes:
measure: Change in weight
timeFrame: From baseline to week 12
measure: BMI (body mass index) changes
timeFrame: From baseline to week 12
measure: Change in waist circumference
timeFrame: From baseline to week 12
measure: Change in hip circumference
timeFrame: From baseline to week 12
measure: Changes in diastolic and systolic blood pressure
timeFrame: From baseline to week 12
measure: Changes in body composition
timeFrame: From baseline to week 12
measure: Change in glucose concentration
timeFrame: From baseline to week 12
measure: Change in insulin concentration
timeFrame: From baseline to week 12
measure: Change in glycated haemoglobin concentration
timeFrame: From baseline to week 12
measure: Change in Triglycerides concentration
timeFrame: From baseline to week 12
measure: Change in cholesterol concentration
timeFrame: From baseline to week 12
measure: Change in HDL concentration
timeFrame: From baseline to week 12
measure: Change in LDL concentration
timeFrame: From baseline to week 12
measure: Change in transaminases concentration
timeFrame: From baseline to week 12
measure: Change in creatinine concentration
timeFrame: From baseline to week 12
measure: Change in uric acid concentration
timeFrame: From baseline to week 12
measure: Change in alkaline phosphatase concentration
timeFrame: From baseline to week 12
measure: Change in bilirubin concentration
timeFrame: From baseline to week 12
measure: Change in lactate concentration
timeFrame: From baseline to week 12
measure: Change in cortisol concentration
timeFrame: From baseline to week 12
measure: Change in total and free testosterone concentration
timeFrame: From baseline to week 12
measure: Change in melatonine concentration
timeFrame: From baseline to week 12
measure: Characterize exercise participant behavior
timeFrame: From baseline to week 12
measure: Mediterranean diet adherence questionnaire
timeFrame: From baseline to week 12
measure: Change in faecal microbiota
timeFrame: From baseline to week 12
measure: Change in fitness mitochondrial
timeFrame: From baseline to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: Hospital Universitario Virgen de la Victoria
name: Mora Murri Pierri, PhD
role: PRINCIPAL_INVESTIGATOR
References: