- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05919979
Effect of a Physical Exercise Session Performed During a 24-34 Hour Fasting Period on Energy Metabolism and Cognitive Function in Healthy Adults (IMS)
December 18, 2025 updated by: Guillermo Sanchez Delgado, Universidad de Granada
Efecto de Una sesión de Ejercicio físico Realizada Durante un Periodo de Ayuno de 24-34 Horas Sobre el Metabolismo energético y la función Cognitiva en Adultos Sanos: Estudio Piloto
This study explores the impact of high-intensity exercise during fasting on energy metabolism and cognitive function in healthy adults.
Changes in respiratory exchange ratio, blood substances, and cognitive performance will be measured after 24 and 34 hours of fasting with and without exercise in a randomized crossover design.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Granada
-
Granada, Granada, Spain, 18007
- Instiuto Mixto Universitario Deporte y Salud
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-40 years old.
- Body mass index: 18.5-30.0 Kg/m2.
- Stable body weight (5kg range within the last 3 months)
- Being able to consume all the food items provided as part of the study.
- Not having change the time zone or have shifted sleeping hours equivalent to more than 3 hours on the previous 2 weeks.
Exclusion Criteria:
- Diagnosed with any chronic condition that, in the research team's opinion or based on the American College of Sports Medicine guidelines, could contraindicate the implementation of 34-hour fasting periods and/or high-intensity exercise.
- Diagnosed with a chronic endocrine, digestive, rheumatic, neurological, cardiac, pulmonary, autoimmune, or infectious condition that affects energy metabolism.
- Presenting any signs or symptoms of illness that, in the research team's opinion or based on the American College of Sports Medicine guidelines, could contraindicate the implementation of 34-hour fasting periods and/or high-intensity exercise.
- Pregnant or breastfeeding.
- Using medications or supplements that may alter energy metabolism.
- Currently undergoing or having undergone any type of nutritional intervention or treatment in the past 3 months.
- Engaging in more than 5 hours per week of habitual moderate-to-vigorous cycling.
- Any other condition that, in the research team's opinion, discourages participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fasting, then fasting+exercise
|
Participants will fast for 34h after a standardized breakfast, refraining from physical activity.
Participants will fast for 34h after a standardized breakfast, performing a high-intensity exercise session 6-10 hours aprox.
after starting the fasting period.
|
|
Experimental: Fasting + Exercise, then fasting
|
Participants will fast for 34h after a standardized breakfast, refraining from physical activity.
Participants will fast for 34h after a standardized breakfast, performing a high-intensity exercise session 6-10 hours aprox.
after starting the fasting period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Respiratory Exchange Ratio
Time Frame: 24-hour after starting the fasting period
|
24-hour after starting the fasting period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Respiratory Exchange Ratio
Time Frame: 34-hour after starting the fasting period
|
34-hour after starting the fasting period
|
|
Serum insulin concentration
Time Frame: 24-hour after starting the fasting period
|
24-hour after starting the fasting period
|
|
Serum insulin concentration
Time Frame: 34-hour after starting the fasting period
|
34-hour after starting the fasting period
|
|
Serum glucose concentration
Time Frame: 24-hour after starting the fasting period
|
24-hour after starting the fasting period
|
|
Serum glucose concentration
Time Frame: 34-hour after starting the fasting period
|
34-hour after starting the fasting period
|
|
Dimensional Change Card Sort Test (NIH toolbox)
Time Frame: 24-hour after starting the fasting period
|
24-hour after starting the fasting period
|
|
Dimensional Change Card Sort Test (NIH toolbox)
Time Frame: 34-hour after starting the fasting period
|
34-hour after starting the fasting period
|
|
List Sorting Working Memory Test (NIH toolbox)
Time Frame: 24-hour after starting the fasting period
|
24-hour after starting the fasting period
|
|
List Sorting Working Memory Test (NIH toolbox)
Time Frame: 34-hour after starting the fasting period
|
34-hour after starting the fasting period
|
|
Flanker Test (NIH toolbox)
Time Frame: 24-hour after starting the fasting period
|
24-hour after starting the fasting period
|
|
Flanker Test (NIH toolbox)
Time Frame: 34-hour after starting the fasting period
|
34-hour after starting the fasting period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2023
Primary Completion (Actual)
June 11, 2025
Study Completion (Actual)
June 18, 2025
Study Registration Dates
First Submitted
June 5, 2023
First Submitted That Met QC Criteria
June 15, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
December 26, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- GSD-2023-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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