PI19/00507: Target Mitochondrial Fitness, Chronobiology and Metabolism

Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05600192
Collaborator
(none)
100
1
1
26.4
3.8

Study Details

Study Description

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:
    • 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).
Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic or anaerobic exercise
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Target Mitochondrial Fitness, Chronobiology and Metabolism
Actual Study Start Date :
Oct 18, 2021
Actual Primary Completion Date :
Jul 29, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise arm

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

Other: Aerobic or anaerobic exercise
Aerobic or anaerobic exercise in the morning or in the afternoon

Outcome Measures

Primary Outcome Measures

  1. Change in weight [From baseline to week 12]

    Weight in kg

  2. BMI (body mass index) changes [From baseline to week 12]

    Measured by body composition analysis

  3. Change in waist circumference [From baseline to week 12]

    Circumference in cm

  4. Change in hip circumference [From baseline to week 12]

    Circumference in cm

  5. Changes in diastolic and systolic blood pressure [From baseline to week 12]

    To analyze the effect of exercise on blood pressure

  6. Changes in body composition [From baseline to week 12]

    To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis

  7. Change in glucose concentration [From baseline to week 12]

    Glucose in mg/dl

  8. Change in insulin concentration [From baseline to week 12]

    Insulin in mg/dl

  9. Change in glycated haemoglobin concentration [From baseline to week 12]

    Glycated haemoglobin in mg/dl

  10. Change in Triglycerides concentration [From baseline to week 12]

    Triglycerides in mg/dl

  11. Change in cholesterol concentration [From baseline to week 12]

    Serum cholesterol in mg/dl

  12. Change in HDL concentration [From baseline to week 12]

    Serum HDL in mg/dl

  13. Change in LDL concentration [From baseline to week 12]

    Serum LDL in mg/dl

  14. Change in transaminases concentration [From baseline to week 12]

    Serum transaminases in UI/l

  15. Change in creatinine concentration [From baseline to week 12]

    Creatinine in mg/dl

  16. Change in uric acid concentration [From baseline to week 12]

    Uric acid in mg/dl

  17. Change in alkaline phosphatase concentration [From baseline to week 12]

    Serum alkaline phosphatase in UI/l

  18. Change in bilirubin concentration [From baseline to week 12]

    Serum bilirubin in mg/dl

  19. Change in lactate concentration [From baseline to week 12]

    Serum lactate in mmol/L

  20. Change in cortisol concentration [From baseline to week 12]

    Serum cortisol in nmol/L

  21. Change in total and free testosterone concentration [From baseline to week 12]

    Serum total and free testosterone in nmol/L

  22. Change in melatonine concentration [From baseline to week 12]

    Serum melatonine in pg/ml

  23. 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.

  24. 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.

  25. 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

  26. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 20-

  • IMC <30 kg/m2

  • Informed consent

Exclusion Criteria:
  • Smoker

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Virgen de la Victoria Málaga Spain 29010

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Mora Murri Pierri, PhD, Hospital Universitario Virgen de la Victoria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier:
NCT05600192
Other Study ID Numbers:
  • PI19/00507
First Posted:
Oct 31, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Study Results

No Results Posted as of Nov 2, 2022