Healthy SubjectsPI19/00507NCT05600192
Target Mitochondrial Fitness, Chronobiology and Metabolism
A study testing Aerobic or anaerobic exercise in people with Healthy Subjects, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Aerobic or anaerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 18 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-
- IMC <30 kg/m2
- Informed consent
Who cannot join
- Smoker
- Previous physical exercise of more than 20 minutes / 2 times a week
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Healthy Subjects
- Being tested
- Aerobic or anaerobic exercise
- Keywords
- Mitochondrial fitness, Metabolism, Chronobiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic or anaerobic exerciseOther
Aerobic or anaerobic exercise in the morning or in the afternoon
| Study group | Role | What they receive |
|---|---|---|
| Exercise arm | Experimental | Subjects perfom aerobic or anaerobic exercise in the morning or in the afternoon Receives: Other: Aerobic or anaerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Weight in kg
Measured: From baseline to week 12
BMI (body mass index) changes
Measured by body composition analysis
Measured: From baseline to week 12
Change in waist circumference
Circumference in cm
Measured: From baseline to week 12
Change in hip circumference
Circumference in cm
Measured: From baseline to week 12
Changes in diastolic and systolic blood pressure
To analyze the effect of exercise on blood pressure
Measured: From baseline to week 12
Changes in body composition
To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis
Measured: From baseline to week 12
Change in glucose concentration
Glucose in mg/dl
Measured: From baseline to week 12
Change in insulin concentration
Insulin in mg/dl
Measured: From baseline to week 12
Change in glycated haemoglobin concentration
Glycated haemoglobin in mg/dl
Measured: From baseline to week 12
Change in Triglycerides concentration
Triglycerides in mg/dl
Measured: From baseline to week 12
Change in cholesterol concentration
Serum cholesterol in mg/dl
Measured: From baseline to week 12
Change in HDL concentration
Serum HDL in mg/dl
Measured: From baseline to week 12
Change in LDL concentration
Serum LDL in mg/dl
Measured: From baseline to week 12
Change in transaminases concentration
Serum transaminases in UI/l
Measured: From baseline to week 12
Change in creatinine concentration
Creatinine in mg/dl
Measured: From baseline to week 12
Change in uric acid concentration
Uric acid in mg/dl
Measured: From baseline to week 12
Change in alkaline phosphatase concentration
Serum alkaline phosphatase in UI/l
Measured: From baseline to week 12
Change in bilirubin concentration
Serum bilirubin in mg/dl
Measured: From baseline to week 12
Change in lactate concentration
Serum lactate in mmol/L
Measured: From baseline to week 12
Change in cortisol concentration
Serum cortisol in nmol/L
Measured: From baseline to week 12
Change in total and free testosterone concentration
Serum total and free testosterone in nmol/L
Measured: From baseline to week 12
Change in melatonine concentration
Serum melatonine in pg/ml
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start18 Oct 2021
- Primary completion29 Jul 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mora Murri Pierri, PhD, Principal investigator, Hospital Universitario Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600192
- Sponsor's protocol ID
- PI19/00507
- Acronym
- PI19/00507
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Mitochondrial Fitness, Chronobiology and Metabolism
- ClinicalTrials.gov ID
- NCT05600192
- Acronym / sponsor ID
- PI19/00507 / PI19/00507
- Conditions
- Healthy Subjects
- Keywords
- Mitochondrial fitness, Metabolism, Chronobiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise arm | Experimental | Other: Aerobic or anaerobic exerciseSubjects perfom aerobic or anaerobic exercise in the morning or in the afternoon |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-
- IMC <30 kg/m2
- Informed consent
Key exclusion criteria (2 listed)
- Smoker
- Previous physical exercise of more than 20 minutes / 2 times a week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic or anaerobic exerciseAerobic or anaerobic exercise in the morning or in the afternoon | Other | Exercise arm |
Primary outcome
Change in weight
Time frame: From baseline to week 12
Weight in kg
BMI (body mass index) changes
Time frame: From baseline to week 12
Measured by body composition analysis
Change in waist circumference
Time frame: From baseline to week 12
Circumference in cm
Change in hip circumference
Time frame: From baseline to week 12
Circumference in cm
Changes in diastolic and systolic blood pressure
Time frame: From baseline to week 12
To analyze the effect of exercise on blood pressure
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
Change in glucose concentration
Time frame: From baseline to week 12
Glucose in mg/dl
Change in insulin concentration
Time frame: From baseline to week 12
Insulin in mg/dl
Change in glycated haemoglobin concentration
Time frame: From baseline to week 12
Glycated haemoglobin in mg/dl
Change in Triglycerides concentration
Time frame: From baseline to week 12
Triglycerides in mg/dl
Change in cholesterol concentration
Time frame: From baseline to week 12
Serum cholesterol in mg/dl
Change in HDL concentration
Time frame: From baseline to week 12
Serum HDL in mg/dl
Change in LDL concentration
Time frame: From baseline to week 12
Serum LDL in mg/dl
Change in transaminases concentration
Time frame: From baseline to week 12
Serum transaminases in UI/l
Change in creatinine concentration
Time frame: From baseline to week 12
Creatinine in mg/dl
Change in uric acid concentration
Time frame: From baseline to week 12
Uric acid in mg/dl
Change in alkaline phosphatase concentration
Time frame: From baseline to week 12
Serum alkaline phosphatase in UI/l
Change in bilirubin concentration
Time frame: From baseline to week 12
Serum bilirubin in mg/dl
Change in lactate concentration
Time frame: From baseline to week 12
Serum lactate in mmol/L
Change in cortisol concentration
Time frame: From baseline to week 12
Serum cortisol in nmol/L
Change in total and free testosterone concentration
Time frame: From baseline to week 12
Serum total and free testosterone in nmol/L
Change in melatonine concentration
Time frame: From baseline to week 12
Serum melatonine in pg/ml
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.
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mora Murri Pierri, PhD principal investigator
Hospital Universitario Virgen de la Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic or anaerobic exercise in people with Healthy Subjects, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: From baseline to week 12). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.