Clinical trial NCT05369715: Diurnal Variation of Exercise on Metabolic Health
Official title: Diurnal Variation of the Effect of Aerobic Exercise on Glycemic Metabolism and Fat Oxidation in Humans: Role of Sex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerobic Exercise
Acute Exercise
Circadian Rhythm Sleep-Wake Disorders, Unspecified Type
Glucose Metabolism
Lipid Metabolism
Diurnal Variation
Young Adults
Keywords: Aerobic Exercise
Diurnal Variation
Circadian Rhythm
Glucose Metabolism
Lipid Metabolism
Young adults
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from resting blood glucose to 48 hours after exercise
timeFrame: 4 days. Pre exercise day, exercise day, post-24hrs exercise day, post-48hrs exercise day.
measure: Change from resting fat oxidation to 90 minutes after exercise
timeFrame: 210 minutes
measure: Change from resting markers of glucose metabolism to 90 minutes after exercise
timeFrame: 180 minutes
measure: Change from resting markers of fatty acid metabolism to 90 minutes after exercise
timeFrame: 180 minutes
measure: Gene expression
timeFrame: 90 minutes
measure: Protein expression
timeFrame: 90 minutes
measure: Mitochondrial breathing
timeFrame: 90 minutes
measure: Mitochondrial supercomplexes
timeFrame: 90 minutes
Secondary outcomes:
measure: Change from resting appetite to 90 minutes after exercise
timeFrame: 180 minutes
Other outcomes:
measure: Continous body temperature
timeFrame: 255
measure: Diet
timeFrame: 4 days. Pre-exercise day, exercise day, post-24 hrs exercise and post-48 hrs exercise
measure: Physical activity
timeFrame: 4 days. Pre-exercise day, exercise day, post-24 hrs exercise and post-48 hrs exercise
measure: Body composition
timeFrame: 7 minutes
measure: Body mass index (BMI)
timeFrame: 5 minutes
measure: Chronotype
timeFrame: 15 minutes
measure: Menstrual cycle
timeFrame: 5 minutes
Locations:
city: Granada
country: Spain
facility: University of Granada - Instituto Mixto Universitario Deporte y Salud
Study officials:
affiliation: Granada University
name: Jonatan Ruiz Ruiz, Dr.
role: PRINCIPAL_INVESTIGATOR
References: