Diurnal Variation of Exercise on Metabolic Health

NCT ID: NCT05369715

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2023-07-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Morning

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Aerobic exercise

Evening

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Aerobic exercise

Interventions

Exercise

Aerobic exercise

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Jonatan Ruiz Ruiz

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonatan Ruiz Ruiz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Granada University

Locations

University of Granada - Instituto Mixto Universitario Deporte y Salud

Granada, , Spain

Countries

Spain

Other Identifiers

DIVA project

Identifier Type: -

Identifier Source: org_study_id