Aerobic ExerciseDIVANCT05369715
Diurnal Variation of Exercise on Metabolic Health
A study testing Exercise in people with Aerobic Exercise and Acute Exercise, run by Universidad de Granada at 1 site in Spain.
Trial summary
The main objective of this project is to study the diurnal variation of the effect of exercise on glycemic metabolism and fat oxidation in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise, Acute Exercise, Circadian Rhythm Sleep-Wake Disorders, Unspecified Type
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2022to 28 Jul 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index: 18.5to 27.0 kg/m2.
- Physical activty < 5 days/week.
- To be able to understand instrucctions, objectives and study protocol.
Who cannot join
- History of a major adverse cardiovascular event, kidney failure, cirrhosis, eating disorder, weight control surgery, or HIV / AIDS.
- Rheumatoid arthritis, Parkinson's disease, active cancer treatment in the past year, type 1 diabetes mellitus, or another medical condition for which fasting is contraindicated.
- Any condition that, in the judgment of the investigator, impairs the ability to participate in the study or poses a personal risk to the participant.
- Use of medications that may affect the results of the study.
- Unstable body weight for 3 months before the start of the study (> 4 kg weight loss or gain)
- Pregnancy and breastfeeding.
- Active tobacco abuse or illicit drug use or a history of alcohol abuse treatment.
- On a special diet or prescribed for other reasons (eg celiac disease).
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Granada - Instituto Mixto Universitario Deporte y Salud
Granada, 18011
About this study
Official title: Diurnal Variation of the Effect of Aerobic Exercise on Glycemic Metabolism and Fat Oxidation in Humans: Role of Sex
The main objective of this project is to study the diurnal variation of the effect of exercise on glycemic metabolism and fat oxidation in humans.
Read the detailed description
Strong scientific evidence supports the beneficial effects of exercise on cardiovascular health, the regulation of glucose metabolism, and fat oxidation. Physical performance capacity is known to fluctuate throughout the day, however, it is unknown whether there is an optimal time of day to maximize the effects of exercise on health, and specifically on blood glucose metabolism and fat oxidation. Finding the ideal time to perform physical exercise is of clinical and public health interest. Likewise, optimizing the timing of physical exercise to coincide with the greater physiological response of each individual would mean increasing the potential of exercise as a therapeutic tool.
Specific aims of this project are a) to describe possible differences dependent on sex in the diurnal variation of the effect of exercise on glycemic metabolism and fat oxidation, and b) to characterize the molecular mechanisms implicated.
18 men and 17 women with normal weight will be randomized into two conditions (morning and evening) with at least 3 days of separation in between. Each evaluation will conform the following tests:
- Basal metabolic rate assessment through indirect calorimetry during 30 minutes.
- Fuel oxidation and energy expenditure assesment during a 60 minutes bout of aerobic steady-state exercise (cycling), through indirect calorimetry.
- Fuel oxidation and energy expenditure assesment after exercise during 30 minutes, through indirect calorimetry.
- Blood samples assesment before, inmediately after, and 90 minutes after exercise.
- Quadriceps biopsies before, and inmediately after exercise. *This will be done only in a sub-cohort.
- Visual analog scales to assess appetite before, inmediately after, and 90 minutes after exercise.
- Continous glucose monitoring from the previous 24 hrs to first session day, until 48 hrs after the last exercise session.
Previous to this, participants' body composition and fitness level will be assesed via densitometry and a maximal exercise test, respectively.
- Conditions
- Aerobic Exercise, Acute Exercise, Circadian Rhythm Sleep-Wake Disorders, Unspecified Type, Glucose Metabolism, Lipid Metabolism, Diurnal Variation
- Being tested
- Exercise
- Keywords
- Aerobic Exercise, Diurnal Variation, Circadian Rhythm, Glucose Metabolism, Lipid Metabolism, Young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Morning | Experimental | 60 minutes cycling on cycle ergometer in the morning (11:30). Steady-state test at an intensity of 65% of participant's heart rate reserve. Receives: Other: Exercise |
| Evening | Experimental | 60 minutes cycling on cycle ergometer in the evening (18:30). Steady-state test at an intensity of 65% of participant's heart rate reserve. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from resting blood glucose to 48 hours after exercise
A continuous glucose monitor inserted into the skin of the arm upper forearm area will be used to record and store blood glucose levels every 15 minutes, for 24 hours, 14 consecutive days. Within this time range both exercise conditions will be performed. The monitor will be placed 24 hours before the first exercise session and will be removed 48 hours after the second exercise session. Therefore, change from resting blood glucose 24 hours previous to 48 hours after exercise will be obtained for each condition.
Measured: 4 days. Pre exercise day, exercise day, post-24hrs exercise day, post-48hrs exercise day.
Change from resting fat oxidation to 90 minutes after exercise
Participants will lay down for 60 minutes where resting gas exchange was measured (using a canopy hood for gases collection) for 30 minutes in two separated 15 minutes stages, corresponding to 45 to 60 and 75 to 90 minutes after exercise, respectively
Measured: 210 minutes
Change from resting markers of glucose metabolism to 90 minutes after exercise
Blood samples will be taken after exercise, immediately after exercise and 90 minutes after exercise, in order to measure change in plasma concentration of markers of glucose metabolism from resting to 90 minutes after exercise.
Measured: 180 minutes
Change from resting markers of fatty acid metabolism to 90 minutes after exercise
Blood samples will be taken to measure plasma concentration of markers of fatty acid metabolism before, immediately after and 90 minutes after exercise.
Measured: 180 minutes
Gene expression
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and immersed in liquid nitrogen and stored at -80ºC until further analysis (i.e.: transcriptomics). RNA from skeletal muscle will be extracted using Trizol (Invitrogen).
Measured: 90 minutes
Protein expression
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and immersed in liquid nitrogen and stored at -80ºC until further analysis (i.e.: proteomics).
Measured: 90 minutes
Mitochondrial breathing
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and treated fresh to study mitochondrial respiration.
Measured: 90 minutes
Mitochondrial supercomplexes
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and immersed in liquid nitrogen and stored at -80ºC until further analysis (i.e.: mitochondrial protein supercomplexes by blue-native PAGE).
Measured: 90 minutes
Secondary outcomes (1)
Change from resting appetite to 90 minutes after exercise
Measures of appetite before, immediately after and 90 minutes after exercise using an appetite visual analog scale (appetite VAS) scoring from 0 to 10, where 0 is the minimum punctuation for appetite and 10 is the maximum punctuation for appetite.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start11 Feb 2022
- Primary completion25 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
- Investigators
- Jonatan Ruiz Ruiz, Dr., Principal investigator, Granada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369715
- Sponsor's protocol ID
- DIVA project
- Acronym
- DIVA
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2021
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Variation of the Effect of Aerobic Exercise on Glycemic Metabolism and Fat Oxidation in Humans: Role of Sex
- ClinicalTrials.gov ID
- NCT05369715
- Acronym / sponsor ID
- DIVA / DIVA project
- Conditions
- Aerobic Exercise, Acute Exercise, Circadian Rhythm Sleep-Wake Disorders, Unspecified Type, Glucose Metabolism, Lipid Metabolism, Diurnal Variation
- Keywords
- Aerobic Exercise, Diurnal Variation, Circadian Rhythm, Glucose Metabolism, Lipid Metabolism, Young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 11 May 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.
The main objective of this project is to study the diurnal variation of the effect of exercise on glycemic metabolism and fat oxidation in humans.
Detailed description
Strong scientific evidence supports the beneficial effects of exercise on cardiovascular health, the regulation of glucose metabolism, and fat oxidation. Physical performance capacity is known to fluctuate throughout the day, however, it is unknown whether there is an optimal time of day to maximize the effects of exercise on health, and specifically on blood glucose metabolism and fat oxidation. Finding the ideal time to perform physical exercise is of clinical and public health interest. Likewise, optimizing the timing of physical exercise to coincide with the greater physiological response of each individual would mean increasing the potential of exercise as a therapeutic tool.
Specific aims of this project are a) to describe possible differences dependent on sex in the diurnal variation of the effect of exercise on glycemic metabolism and fat oxidation, and b) to characterize the molecular mechanisms implicated.
18 men and 17 women with normal weight will be randomized into two conditions (morning and evening) with at least 3 days of separation in between. Each evaluation will conform the following tests:
- Basal metabolic rate assessment through indirect calorimetry during 30 minutes.
- Fuel oxidation and energy expenditure assesment during a 60 minutes bout of aerobic steady-state exercise (cycling), through indirect calorimetry.
- Fuel oxidation and energy expenditure assesment after exercise during 30 minutes, through indirect calorimetry.
- Blood samples assesment before, inmediately after, and 90 minutes after exercise.
- Quadriceps biopsies before, and inmediately after exercise. *This will be done only in a sub-cohort.
- Visual analog scales to assess appetite before, inmediately after, and 90 minutes after exercise.
- Continous glucose monitoring from the previous 24 hrs to first session day, until 48 hrs after the last exercise session.
Previous to this, participants' body composition and fitness level will be assesed via densitometry and a maximal exercise test, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning | Experimental | Other: Exercise60 minutes cycling on cycle ergometer in the morning (11:30). Steady-state test at an intensity of 65% of participant's heart rate reserve. |
| Evening | Experimental | Other: Exercise60 minutes cycling on cycle ergometer in the evening (18:30). Steady-state test at an intensity of 65% of participant's heart rate reserve. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index: 18.5to 27.0 kg/m2.
- Physical activty < 5 days/week.
- To be able to understand instrucctions, objectives and study protocol.
Key exclusion criteria (8 listed)
- History of a major adverse cardiovascular event, kidney failure, cirrhosis, eating disorder, weight control surgery, or HIV / AIDS.
- Rheumatoid arthritis, Parkinson's disease, active cancer treatment in the past year, type 1 diabetes mellitus, or another medical condition for which fasting is contraindicated.
- Any condition that, in the judgment of the investigator, impairs the ability to participate in the study or poses a personal risk to the participant.
- Use of medications that may affect the results of the study.
- Unstable body weight for 3 months before the start of the study (> 4 kg weight loss or gain)
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 |
|---|---|---|
| ExerciseAerobic exercise | Other | Evening, Morning |
Primary outcome
Change from resting blood glucose to 48 hours after exercise
Time frame: 4 days. Pre exercise day, exercise day, post-24hrs exercise day, post-48hrs exercise day.
A continuous glucose monitor inserted into the skin of the arm upper forearm area will be used to record and store blood glucose levels every 15 minutes, for 24 hours, 14 consecutive days. Within this time range both exercise conditions will be performed. The monitor will be placed 24 hours before the first exercise session and will be removed 48 hours after the second exercise session. Therefore, change from resting blood glucose 24 hours previous to 48 hours after exercise will be obtained for each condition.
Change from resting fat oxidation to 90 minutes after exercise
Time frame: 210 minutes
Participants will lay down for 60 minutes where resting gas exchange was measured (using a canopy hood for gases collection) for 30 minutes in two separated 15 minutes stages, corresponding to 45 to 60 and 75 to 90 minutes after exercise, respectively
Change from resting markers of glucose metabolism to 90 minutes after exercise
Time frame: 180 minutes
Blood samples will be taken after exercise, immediately after exercise and 90 minutes after exercise, in order to measure change in plasma concentration of markers of glucose metabolism from resting to 90 minutes after exercise.
Change from resting markers of fatty acid metabolism to 90 minutes after exercise
Time frame: 180 minutes
Blood samples will be taken to measure plasma concentration of markers of fatty acid metabolism before, immediately after and 90 minutes after exercise.
Gene expression
Time frame: 90 minutes
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and immersed in liquid nitrogen and stored at -80ºC until further analysis (i.e.: transcriptomics). RNA from skeletal muscle will be extracted using Trizol (Invitrogen).
Protein expression
Time frame: 90 minutes
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and immersed in liquid nitrogen and stored at -80ºC until further analysis (i.e.: proteomics).
Mitochondrial breathing
Time frame: 90 minutes
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and treated fresh to study mitochondrial respiration.
Mitochondrial supercomplexes
Time frame: 90 minutes
Muscular biopsies will be taken from the vastus lateralis' distal part of the quadriceps in a sub-sample before and immediately after the exercise. Biopsies will be performed by an experienced surgeon using microbiopsy needles (Achieve Automatic Needle 16G x 15 cm), obtaining ~30 mg per biopsy after previous local anaesthesia with 2% lidocaine. From each time point (Pre and Post), 1 skeletal muscle samples will be collected and immersed in liquid nitrogen and stored at -80ºC until further analysis (i.e.: mitochondrial protein supercomplexes by blue-native PAGE).
1 secondary outcome
Change from resting appetite to 90 minutes after exercise
Time frame: 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
Jonatan Ruiz Ruiz, Dr. principal investigator
Granada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aerobic Exercise and Acute Exercise, run by Universidad de Granada 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 8 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: finished, as of the sponsor's last update on 1 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from resting blood glucose to 48 hours after exercise (time frame: 4 days. Pre exercise day, exercise day, post-24hrs exercise day, post-48hrs exercise day.). The study lists 8 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 1 Feb 2024.