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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05627804
Other study ID # ISNRP-003-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date August 1, 2023

Study information

Verified date November 2023
Source Swinburne University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is a major global health issue and a primary risk factor for metabolic-related disorders. While physical inactivity is one of the main contributors to obesity, it is a modifiable risk factor with exercise training as an established, non-pharmacological treatment to prevent the onset of metabolic-related disorders, including obesity. Exposure to low-oxygen availability (hypoxia) via normobaric hypoxia (simulated altitude via reduced inspired oxygen fraction), termed hypoxic conditioning, in combination with exercise has been increasingly shown in the last decade to enhance blood glucose regulation and decrease body mass index, providing a feasible strategy to treat obesity. However, findings from studies investigating the potential for hypoxia to augment the exercise training response and subsequent metabolic health are equivocal. Notably, there is a lack of information regarding the optimal combination of exercise variables and hypoxic severity to enable an individualized and safe practice of exercising in a hypoxic environment. In the present randomized, single-blind, cross-over study, the investigators will investigate the effects of single-bout of different exercise modes under moderate hypoxia (FiO2, 16.5%). The investigators hypothesize that all exercises combined with hypoxia improve glucose homeostasis in overweight individuals.


Description:

In the present randomized, single-blind, cross-over study, participants will be exposed to moderate hypoxia (oxygen level 16.5%) during three different exercises (low-intensity cycling, sprint interval and functional exercises). Participants will be randomly assigned to each exercise condition (computer-generated randomization plan), separated by a washout period (5-7 days). To accomplish this, participants will exercise in an environmental chamber in which oxygen concentration of the ambient air and, as such, oxygen levels can be closely controlled and monitored. Participants are required to attend the laboratory 8 times. These visits are including pre-exercise screening, baseline blood sampling, body composition screening and exercise in altitude conditions.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date August 1, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - BMI is between 25-29 kg/m² - Physical inactive (physical activity <150 min/week) - No known heart or metabolic diseases (such as Type 2 diabetes) - Not currently taking any prescribed medication - No reported musculoskeletal injuries recently - Not exposed to hypoxia >1000 m prior to the study Exclusion Criteria: - Impaired glucose tolerance (2 hour glucose: >7.8 - 11.1 mmol/L) - Type 2 diabetes mellitus - Obstructive sleep apnea - Chronic obstructive pulmonary disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low-moderate intensity exercise
The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia
Sprint interval training
The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.
Functional exercise
The participants will perform bodyweight exercises under moderate hypoxia.
Control
No exercise will be performed.

Locations

Country Name City State
Malaysia National Sports Institute of Malaysia Kuala Lumpur

Sponsors (2)

Lead Sponsor Collaborator
Swinburne University of Technology National Sports Institute of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oral glucose tolerance test (glucose) Change of plasma glucose concentration immediately post-exercise under different exercise modes Change of fasting and postprandial plasma glucose concentrations compared to different exercise mode at immediately after exercise
Primary Oral glucose tolerance test (insulin) Change of plasma insulin concentration immediately post-exercise under different exercise modes Change of fasting and postprandial plasma insulin concentrations compared to different exercise mode at immediately after exercise
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