Target Mitochondrial Fitness, Chronobiology and Metabolism

NCT ID: NCT05600192

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-12-31

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).

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Exercise arm

Subjects perfom aerobic or anaerobic exercise in the morning or in the afternoon

Group Type: EXPERIMENTAL

Aerobic or anaerobic exercise

Intervention Type: OTHER

Aerobic or anaerobic exercise in the morning or in the afternoon

Interventions

Aerobic or anaerobic exercise

Aerobic or anaerobic exercise in the morning or in the afternoon

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mora Murri Pierri, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Victoria

Locations

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Countries

Spain

Other Identifiers

PI19/00507

Identifier Type: -

Identifier Source: org_study_id