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Diurnal Variation of Exercise on Metabolic Health

Diurnal Variation of the Effect of Aerobic Exercise on Glycemic Metabolism and Fat Oxidation in Humans: Role of Sex

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05369715
Acronym
DIVA
Enrollment
35
Registered
2022-05-11
Start date
2022-02-11
Completion date
2023-07-28
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exercise, Aerobic Exercise, Circadian Rhythm Sleep-Wake Disorders, Unspecified Type, Diurnal Variation, Glucose Metabolism, Lipid Metabolism, Young Adults

Keywords

Aerobic Exercise, Diurnal Variation, Circadian Rhythm, Glucose Metabolism, Lipid Metabolism, Young adults

Brief 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.

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: 1. Basal metabolic rate assessment through indirect calorimetry during 30 minutes. 2. Fuel oxidation and energy expenditure assesment during a 60 minutes bout of aerobic steady-state exercise (cycling), through indirect calorimetry. 3. Fuel oxidation and energy expenditure assesment after exercise during 30 minutes, through indirect calorimetry. 4. Blood samples assesment before, inmediately after, and 90 minutes after exercise. 5. Quadriceps biopsies before, and inmediately after exercise. \*This will be done only in a sub-cohort. 6. Visual analog scales to assess appetite before, inmediately after, and 90 minutes after exercise. 7. 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.

Interventions

OTHERExercise

Aerobic exercise

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

To blind this study is not possible due to the studied conditions: morning and evening. Only data assesors can be blinded.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index: 18.5to 27.0 kg/m2. * Physical activty \< 5 days/week. * To be able to understand instrucctions, objectives and study protocol.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Mitochondrial supercomplexes90 minutesMuscular 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).
Change from resting markers of fatty acid metabolism to 90 minutes after exercise180 minutesBlood samples will be taken to measure plasma concentration of markers of fatty acid metabolism before, immediately after and 90 minutes after exercise.
Change from resting blood glucose to 48 hours after exercise4 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 exercise210 minutesParticipants 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 exercise180 minutesBlood 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.
Gene expression90 minutesMuscular 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 expression90 minutesMuscular 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 breathing90 minutesMuscular 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.

Secondary

MeasureTime frameDescription
Change from resting appetite to 90 minutes after exercise180 minutesMeasures 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.

Other

MeasureTime frameDescription
Diet4 days. Pre-exercise day, exercise day, post-24 hrs exercise and post-48 hrs exerciseStandarditation and control of diet. Diet will be standardized 24 hours prior to each exercise session (55% carbohydrates, 27% fat and 18% proteins). In addition, diet will be monitored for 48 hours after the exercise test.
Physical activity4 days. Pre-exercise day, exercise day, post-24 hrs exercise and post-48 hrs exerciseLevels of physical activity will be controlled by accelerometry 24 hours before and 48 hours after each exercise session (Actigraph, GT3X).
Body composition7 minutesBody fat percentage will be evaluated by dual X-ray absorptiometry (Discovery Wi, Hologic, Inc, Bedford, MA, USA).
Continous body temperature255Before, during and after exercise, periodic recordings of the central and distal temperature will also be made by using thermal iButtons (iButtons DS 1922 L, Maxim, Dallas, USA).
Chronotype15 minutesParticipants will complete the HÖME questionnaire, that determines chronotype (morning-evening).
Menstrual cycle5 minutesDates of the different phases of the menstrual cycle will be recorded in order to locate all tests in the luteal phase. However, we have observed that fat oxidation is not affected by the phase of the menstrual cycle
Body mass index (BMI)5 minutesWeight and height will be measured (Seca model 799, Electronic Column Scale, Hamburg, Germany). Weight and height measurements will be aggregated to obtain BMI in kg/m\^2

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026