## Protocol Section
### Identification Module
**NCT ID:** NCT05919979

**Acronym:** IMS

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

**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

#### Organization Study ID Info
**ID:** GSD-2023-002
#### Organization
**Class:** OTHER
**Full Name:** Universidad de Granada
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-03

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2023-06-27
**Type:** ACTUAL
**Study First Submit Date:** 2023-06-05
**Study First Submit QC Date:** 2023-06-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad de Granada

#### Responsible Party

**Investigator Affiliation:** Universidad de Granada

**Investigator Full Name:** Guillermo Sanchez Delgado

**Investigator Title:** Postdoctoral Researcher

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Energy Metabolism

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: 34-hour fasting in sedentary conditions

- Behavioral: 34-hour fasting with high-intensity exercise

**Label:** Fasting, then fasting+exercise

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: 34-hour fasting in sedentary conditions

- Behavioral: 34-hour fasting with high-intensity exercise

**Label:** Fasting + Exercise, then fasting

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fasting + Exercise, then fasting

- Fasting, then fasting+exercise

**Description:** Participants will fast for 34h after a standardized breakfast, refraining from physical activity.

**Name:** 34-hour fasting in sedentary conditions

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Fasting + Exercise, then fasting

- Fasting, then fasting+exercise

**Description:** Participants will fast for 34h after a standardized breakfast, performing a high-intensity exercise session 6-10 hours aprox. after starting the fasting period.

**Name:** 34-hour fasting with high-intensity exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Respiratory Exchange Ratio

**Time Frame:** 24-hour after starting the fasting period

#### Secondary Outcomes

**Measure:** Respiratory Exchange Ratio

**Time Frame:** 34-hour after starting the fasting period

**Measure:** Serum insulin concentration

**Time Frame:** 24-hour after starting the fasting period

**Measure:** Serum insulin concentration

**Time Frame:** 34-hour after starting the fasting period

**Measure:** Serum glucose concentration

**Time Frame:** 24-hour after starting the fasting period

**Measure:** Serum glucose concentration

**Time Frame:** 34-hour after starting the fasting period

**Measure:** Dimensional Change Card Sort Test (NIH toolbox)

**Time Frame:** 24-hour after starting the fasting period

**Measure:** Dimensional Change Card Sort Test (NIH toolbox)

**Time Frame:** 34-hour after starting the fasting period

**Measure:** List Sorting Working Memory Test (NIH toolbox)

**Time Frame:** 24-hour after starting the fasting period

**Measure:** List Sorting Working Memory Test (NIH toolbox)

**Time Frame:** 34-hour after starting the fasting period

**Measure:** Flanker Test (NIH toolbox)

**Time Frame:** 24-hour after starting the fasting period

**Measure:** Flanker Test (NIH toolbox)

**Time Frame:** 34-hour after starting the fasting period

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gsanchezdelgado@ugr.es

**Name:** Guillermo Sanchez Delgado, PhD

**Phone:** +34665186487

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Granada

**Contacts:**

***Contact 1:***

- **Name:** Guillermo Sanchez Delgado, PhD

- **Role:** CONTACT

**Country:** Spain

**Facility:** Instiuto Mixto Universitario Deporte y Salud

**Status:** RECRUITING

**Zip:** 18007

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
