Target Mitochondrial Fitness, Chronobiology and Metabolism

NCT05600192 | Unknown

• 1 other identifier: PI19/00507
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 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

Keywords

Mitochondrial fitness; Metabolism; Chronobiology

Outcome Measures

Primary Outcomes (26)

• Change in weight

  Weight in kg

  From baseline to week 12

• BMI (body mass index) changes

  Measured by body composition analysis

  From baseline to week 12

• Change in waist circumference

  Circumference in cm

  From baseline to week 12

• Change in hip circumference

  Circumference in cm

  From baseline to week 12

• Changes in diastolic and systolic blood pressure

  To analyze the effect of exercise on blood pressure

  From baseline to week 12

• Changes in body composition

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

  From baseline to week 12

• Change in glucose concentration

  Glucose in mg/dl

  From baseline to week 12

• Change in insulin concentration

  Insulin in mg/dl

  From baseline to week 12

• Change in glycated haemoglobin concentration

  Glycated haemoglobin in mg/dl

  From baseline to week 12

• Change in Triglycerides concentration

  Triglycerides in mg/dl

  From baseline to week 12

• Change in cholesterol concentration

  Serum cholesterol in mg/dl

  From baseline to week 12

• Change in HDL concentration

  Serum HDL in mg/dl

  From baseline to week 12

• Change in LDL concentration

  Serum LDL in mg/dl

  From baseline to week 12

• Change in transaminases concentration

  Serum transaminases in UI/l

  From baseline to week 12

• Change in creatinine concentration

  Creatinine in mg/dl

  From baseline to week 12

• Change in uric acid concentration

  Uric acid in mg/dl

  From baseline to week 12

• Change in alkaline phosphatase concentration

  Serum alkaline phosphatase in UI/l

  From baseline to week 12

• Change in bilirubin concentration

  Serum bilirubin in mg/dl

  From baseline to week 12

• Change in lactate concentration

  Serum lactate in mmol/L

  From baseline to week 12

• Change in cortisol concentration

  Serum cortisol in nmol/L

  From baseline to week 12

• Change in total and free testosterone concentration

  Serum total and free testosterone in nmol/L

  From baseline to week 12

• Change in melatonine concentration

  Serum melatonine in pg/ml

  From baseline to week 12

• Characterize exercise participant behavior

  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.

  From baseline to week 12

• Mediterranean diet adherence questionnaire

  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.

  From baseline to week 12

• Change in faecal microbiota

  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

  From baseline to week 12

• Change in fitness mitochondrial

  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.

  From baseline to week 12

Study Arms (1)

Exercise arm

EXPERIMENTAL

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

Other: Aerobic or anaerobic exercise

Interventions

Aerobic or anaerobic exercise OTHER

Aerobic or anaerobic exercise in the morning or in the afternoon

Exercise arm

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• IMC \<30 kg/m2
• Informed consent

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Study Officials

• Mora Murri Pierri, PhD

  Hospital Universitario Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: October 18, 2021
• Primary Completion: July 29, 2022
• Study Completion: December 31, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-09

Locations

ES (1)