Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1