IMS: Effect of a Physical Exercise Session Performed During a 24-34 Hour Fasting Period on Energy Metabolism and Cognitive Function in Healthy Adults

• Sponsor: Universidad de Granada (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05919979
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.1
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Energy Metabolism	Behavioral: 34-hour fasting in sedentary conditions; Behavioral: 34-hour fasting with high-intensity exercise	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Actual Study Start Date: May 29, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fasting, then fasting+exercise	Behavioral: 34-hour fasting in sedentary conditions; Participants will fast for 34h after a standardized breakfast, refraining from physical activity.; Behavioral: 34-hour fasting with high-intensity exercise; 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	Behavioral: 34-hour fasting in sedentary conditions; Participants will fast for 34h after a standardized breakfast, refraining from physical activity.; Behavioral: 34-hour fasting with high-intensity exercise; Participants will fast for 34h after a standardized breakfast, performing a high-intensity exercise session 6-10 hours aprox. after starting the fasting period.

Outcome Measures

Primary Outcome Measures

1. Respiratory Exchange Ratio [24-hour after starting the fasting period]

Secondary Outcome Measures

1. Respiratory Exchange Ratio [34-hour after starting the fasting period]

2. Serum insulin concentration [24-hour after starting the fasting period]

3. Serum insulin concentration [34-hour after starting the fasting period]

4. Serum glucose concentration [24-hour after starting the fasting period]

5. Serum glucose concentration [34-hour after starting the fasting period]

6. Dimensional Change Card Sort Test (NIH toolbox) [24-hour after starting the fasting period]

7. Dimensional Change Card Sort Test (NIH toolbox) [34-hour after starting the fasting period]

8. List Sorting Working Memory Test (NIH toolbox) [24-hour after starting the fasting period]

9. List Sorting Working Memory Test (NIH toolbox) [34-hour after starting the fasting period]

10. Flanker Test (NIH toolbox) [24-hour after starting the fasting period]

11. Flanker Test (NIH toolbox) [34-hour after starting the fasting period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instiuto Mixto Universitario Deporte y Salud	Granada		Spain	18007

Sponsors and Collaborators

• Universidad de Granada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Sanchez Delgado, Postdoctoral Researcher, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT05919979
• Other Study ID Numbers: GSD-2023-002
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 27, 2023