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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05919979
Other study ID # GSD-2023-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 29, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Universidad de Granada
Contact Guillermo Sanchez Delgado, PhD
Phone +34665186487
Email gsanchezdelgado@ugr.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
34-hour fasting in sedentary conditions
Participants will fast for 34h after a standardized breakfast, refraining from physical activity.
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.

Locations

Country Name City State
Spain Instiuto Mixto Universitario Deporte y Salud Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory Exchange Ratio 24-hour after starting the fasting period
Secondary Respiratory Exchange Ratio 34-hour after starting the fasting period
Secondary Serum insulin concentration 24-hour after starting the fasting period
Secondary Serum insulin concentration 34-hour after starting the fasting period
Secondary Serum glucose concentration 24-hour after starting the fasting period
Secondary Serum glucose concentration 34-hour after starting the fasting period
Secondary Dimensional Change Card Sort Test (NIH toolbox) 24-hour after starting the fasting period
Secondary Dimensional Change Card Sort Test (NIH toolbox) 34-hour after starting the fasting period
Secondary List Sorting Working Memory Test (NIH toolbox) 24-hour after starting the fasting period
Secondary List Sorting Working Memory Test (NIH toolbox) 34-hour after starting the fasting period
Secondary Flanker Test (NIH toolbox) 24-hour after starting the fasting period
Secondary Flanker Test (NIH toolbox) 34-hour after starting the fasting period
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