- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05600192
Target Mitochondrial Fitness, Chronobiology and Metabolism (PI19/00507)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Málaga, Spain, 29010
- Hospital Universitario Virgen de la Victoria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 20-
- IMC <30 kg/m2
- Informed consent
Exclusion Criteria:
- Smoker
- Previous physical exercise of more than 20 minutes / 2 times a week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise arm
Subjects perfom aerobic or anaerobic exercise in the morning or in the afternoon
|
Aerobic or anaerobic exercise in the morning or in the afternoon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: From baseline to week 12
|
Weight in kg
|
From baseline to week 12
|
BMI (body mass index) changes
Time Frame: From baseline to week 12
|
Measured by body composition analysis
|
From baseline to week 12
|
Change in waist circumference
Time Frame: From baseline to week 12
|
Circumference in cm
|
From baseline to week 12
|
Change in hip circumference
Time Frame: From baseline to week 12
|
Circumference in cm
|
From baseline to week 12
|
Changes in diastolic and systolic blood pressure
Time Frame: From baseline to week 12
|
To analyze the effect of exercise on blood pressure
|
From baseline to week 12
|
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
|
From baseline to week 12
|
Change in glucose concentration
Time Frame: From baseline to week 12
|
Glucose in mg/dl
|
From baseline to week 12
|
Change in insulin concentration
Time Frame: From baseline to week 12
|
Insulin in mg/dl
|
From baseline to week 12
|
Change in glycated haemoglobin concentration
Time Frame: From baseline to week 12
|
Glycated haemoglobin in mg/dl
|
From baseline to week 12
|
Change in Triglycerides concentration
Time Frame: From baseline to week 12
|
Triglycerides in mg/dl
|
From baseline to week 12
|
Change in cholesterol concentration
Time Frame: From baseline to week 12
|
Serum cholesterol in mg/dl
|
From baseline to week 12
|
Change in HDL concentration
Time Frame: From baseline to week 12
|
Serum HDL in mg/dl
|
From baseline to week 12
|
Change in LDL concentration
Time Frame: From baseline to week 12
|
Serum LDL in mg/dl
|
From baseline to week 12
|
Change in transaminases concentration
Time Frame: From baseline to week 12
|
Serum transaminases in UI/l
|
From baseline to week 12
|
Change in creatinine concentration
Time Frame: From baseline to week 12
|
Creatinine in mg/dl
|
From baseline to week 12
|
Change in uric acid concentration
Time Frame: From baseline to week 12
|
Uric acid in mg/dl
|
From baseline to week 12
|
Change in alkaline phosphatase concentration
Time Frame: From baseline to week 12
|
Serum alkaline phosphatase in UI/l
|
From baseline to week 12
|
Change in bilirubin concentration
Time Frame: From baseline to week 12
|
Serum bilirubin in mg/dl
|
From baseline to week 12
|
Change in lactate concentration
Time Frame: From baseline to week 12
|
Serum lactate in mmol/L
|
From baseline to week 12
|
Change in cortisol concentration
Time Frame: From baseline to week 12
|
Serum cortisol in nmol/L
|
From baseline to week 12
|
Change in total and free testosterone concentration
Time Frame: From baseline to week 12
|
Serum total and free testosterone in nmol/L
|
From baseline to week 12
|
Change in melatonine concentration
Time Frame: From baseline to week 12
|
Serum melatonine in pg/ml
|
From baseline to week 12
|
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.
|
From baseline to week 12
|
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.
|
From baseline to week 12
|
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
|
From baseline to week 12
|
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.
|
From baseline to week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mora Murri Pierri, PhD, Hospital Universitario Virgen de la Victoria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI19/00507
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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