Diurnal Variation of Exercise on Metabolic Health

NCT05369715 | Completed

• 1 other identifier: DIVA project
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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.

  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).

  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).

  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.

  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).

  90 minutes

Secondary Outcomes (1)

• Change from resting appetite to 90 minutes after exercise

  180 minutes

Other Outcomes (7)

• Continous body temperature

  255

• Diet

  4 days. Pre-exercise day, exercise day, post-24 hrs exercise and post-48 hrs exercise

• Physical activity

  4 days. Pre-exercise day, exercise day, post-24 hrs exercise and post-48 hrs exercise

Study Arms (2)

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.

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.

Other: Exercise

Interventions

Exercise OTHER

Aerobic exercise

Evening; Morning

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada - Instituto Mixto Universitario Deporte y Salud

Granada, 18011, Spain

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jonatan Ruiz Ruiz, Dr.

  Granada University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To blind this study is not possible due to the studied conditions: morning and evening. Only data assesors can be blinded.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: May 11, 2022
• Study Start: February 11, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 28, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

ES (1)