## Protocol Section
### Identification Module
**NCT ID:** NCT03864679

**Acronym:** FATOX

**Brief Title:** Investigation of Fat Oxidation During Moderate Versus Vigorous Intensity Exercise

**Official Title:** Investigation of Fat and Carbohydrate Oxidation During Moderate Versus Vigorous Intensity Exercise in Healthy Volunteers With Sedentary Lifestyle

#### Organization Study ID Info
**ID:** Exercise 2018-1
#### Organization
**Class:** OTHER
**Full Name:** Latvian Institute of Organic Synthesis
### Status Module
#### Completion Date
**Date:** 2018-08-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-06

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-08-15

**Type:** ACTUAL

#### Start Date
**Date:** 2018-06-18

**Type:** ACTUAL

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2019-03-06
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-22
**Study First Submit QC Date:** 2019-03-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Riga East University Hospital

**Class:** OTHER

**Name:** University of Latvia

**Class:** OTHER

**Name:** Riga Stradins University

#### Lead Sponsor

**Class:** OTHER

**Name:** Latvian Institute of Organic Synthesis

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Exercise is widely suggested as an important lifestyle change for weight loss, however, the optimal level of intensity moderate versus vigorous remains unclear. It is known that in athletes, during very high-intensity exercise, fat oxidation is decreased and energy is gained mainly from carbohydrate utilization. The aim of this study is to find an optimal workload based on fat oxidation rate during exercise in volunteers with a sedentary lifestyle.

**Detailed Description:** It is planned to recruit 12 healthy volunteers with a sedentary lifestyle in the study group. Since different regimens (fed, fasted and moderate versus vigorous) will be compared in the same subjects, no control group is necessary. Subjects will perform a cycling test with 5 min incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load will be selected after the incremental intensity exercise). The expiration of carbon dioxide (CO2) and consumption of oxygen (O2) will be measured, to determine the total fatty acid and carbohydrate oxidation during cycling. Concomitantly, it is planned to measure blood lactate and glucose concentrations during exercise experiments as well as a wide range of blood biochemistry parameters before and after exercise.

The investigators expect to find optimal conditions for the sedentary population for burning of fat, which is the major source of energy during moderate-intensity exercise. Measurements of the fat and carbohydrate oxidation in healthy volunteers with a sedentary lifestyle will contribute to the understanding of exercise regimens for the most effective fat oxidation.

### Conditions Module

**Conditions:**

- Healthy

- Sedentary Lifestyle

**Keywords:**

- exercise

- fed

- fasted

- fat

- carbohydrate

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will perform a cycling tests

**Intervention Names:**

- Other: Exercise

**Label:** Exercise

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise

**Description:** Subjects will perform a cycling test with 5 min incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load will be selected in incremental intensity exercise).

**Name:** Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The exercise workload (W) for optimal fat burning during exercise

**Measure:** Optimal workload

**Time Frame:** 30 min accelerated load cycling exercise

**Description:** Change in heart rate (BPM) from rest to the optimal workload

**Measure:** Heart rate change

**Time Frame:** 30 min accelerated load cycling exercise and 60 min optimal intensity cycling exercise

#### Secondary Outcomes

**Description:** The influence of fed and fasted state on maximal whole body fat oxidation rate during exercise

**Measure:** Influence of fed and fasted state

**Time Frame:** 30 min accelerated load cycling exercise

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy
* Sedentary lifestyle
* BMI 20 - 30 kg/m2
* Be able to attend the laboratory and willing to participate in necessary protocols
* Be willing to undertake the duration of the exercise protocol (3 x 1 hour)
* Have the capacity and willingness to provide informed consent (oral and written)

Exclusion Criteria:

* athletes
* Individuals with chronic cardiovascular disease such as hypertension, valve disease, coronary artery disease, cardiac conduction abnormalities, etc.
* History of pneumothorax or chronic lung disease such as asthma, COPD, bronchiectasis
* Active Smokers
* Pregnant women

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Riga

**Country:** Latvia

**Facility:** Latvian University

**Zip:** LV-1004

#### Overall Officials

**Official 1:**

**Affiliation:** Riga East University Hospital

**Name:** Ilze Konrade

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2019-04-08

- Date Unknown: Unknown

#### Event: RESET

- Date: 2019-06-28

- Date Unknown: Unknown

## Derived Section

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2019-04-08

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2019-04-08

- Reset Date: 2019-06-28

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
