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The Potential of a Low Oxygen Environmental Chamber as an Aid to Exercise Training to Improve Metabolic Health

Primary Purpose

Overweight, Physical Inactivity, Healthy

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Low-moderate intensity exercise under normoxia
Low-moderate intensity exercise under moderate hypoxia
Low-moderate intensity exercise under high hypoxia
Sponsored by
Swinburne University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Hypoxia, Overweight, Glucose tolerance, Exercise

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI is between 25-29 kg/m²
  • Sedentary (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

Sites / Locations

  • National Sports Institute of Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Moderate intensity exercise under normoxia

Moderate intensity exercise under hypoxia

Arm Description

The participants will perform low-moderate intensity cycling exercise at 90% lactate threshold (LT) (determined during LT test) under normoxia (FiO2: 20.9%) for 60 minutes on a cycle ergometer. Immediately after exercise oral glucose tolerance test (OGTT) will be determined with 24-hour glucose concentration will be monitored continuously. Circulatory factors will be determined pre, immediately after exercise and 24 hours after exercise.

The participants will perform low-moderate intensity cycling exercise at 90% lactate threshold (LT) (determined during LT test) under hypoxia (FiO2: 16.5-14.8%) for 60 minutes on a cycle ergometer. Immediately after exercise oral glucose tolerance test (OGTT) will be determined with 24-hour glucose concentration will be monitored continuously. Circulatory factors will be determined pre, immediately after exercise and 24 hours after exercise.

Outcomes

Primary Outcome Measures

Fasting and postprandial plasma glucose concentration
Change of plasma glucose concentration immediately post-exercise under hypoxia (14.8-16.5% oxygen) compared to normoxia.
Fasting and postprandial plasma insulin concentration
Change of plasma insulin concentration immediately post-exercise under hypoxia (14.8-16.5% oxygen) compared to normoxia.

Secondary Outcome Measures

Average 24 hours glucose concentration
Glucose concentration will be measured in the interstitial fluid of the subcutaneous adipose tissue every 15 min using a glucose sensor (FreeStyle Libre, Abbott Diabetes Care, Witney, UK), which will be inserted subcutaneously, under skin on the arm, and will be connected to a continuous glucose monitor (Abbott FreeStyle Libre™). The cumulative effects of the acute single-bout exercise will be determined using the average 24 hours glucose levels collected on post 24 h.
Circulating concentration of fibroblast growth factor 21 (FGF-21)
Moderate intensity exercise under moderate-high hypoxia compared to normoxia. Pre, immediate post and post 24 hours blood will be sampled and analysed for circulating markers by means of ELISA
Circulating concentration of apelin
Moderate intensity exercise under moderate-high hypoxia compared to normoxia. Pre, immediate post and post 24 hours blood will be sampled and analysed for circulating markers by means of ELISA

Full Information

First Posted
September 29, 2022
Last Updated
October 9, 2022
Sponsor
Swinburne University of Technology
Collaborators
National Sports Institute of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05577429
Brief Title
The Potential of a Low Oxygen Environmental Chamber as an Aid to Exercise Training to Improve Metabolic Health
Official Title
The Potential of a Low Oxygen Environmental Chamber as an Aid to Exercise Training to Improve Metabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swinburne University of Technology
Collaborators
National Sports Institute of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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. Nonetheless, findings from studies investigating the potential for a hypoxic environment to augment the exercise training response and subsequent metabolic health are equivocal. Notably, there is a paucity of information regarding the optimal combination of exercise variables and hypoxic load (i.e. level of hypoxia) 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 exercise under normoxia (FiO2, 20.9%), moderate (FiO2, 16.5%) and high normobaric hypoxic conditions (FiO2, 14.8%) (60-min cycling session at 90% LT) on 2h OGTT and 24h-glucose level in individuals with overweight. The investigators hypothesize that exercise in combination with hypoxia improves glucose homeostasis in individuals with overweight.
Detailed Description
In the present randomized, single-blind, cross-over study, participants will be exposed to normobaric 1) normoxia (oxygen level 20.9%), 2) moderate hypoxia (oxygen level 16.5%) and 3) high hypoxia (oxygen level 14.8%) 1) during exercise (60 minutes on a cycle ergometer) at 90% LT. Participants will be randomly assigned to each 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 will cycle for 60 minutes at a 90% lactate threshold (LT), determined by an LT test. Visit 1 (Screening and consent): Introduction to the research team and tour of the facility. Complete and sign the Adult Pre-Exercise Screening System form. Complete and sign the consent information form. Visit 2: Body composition screening using bioimpedance analysis (Inbody 770, Cerritos, CA, USA) Blood pressure screening. Lactate threshold test-participants will be riding a Velotron cycle ergometer (Racermate, Seattle, USA) with an initial load of 50 Watts. The load increased progressively in 15 Watts increments every 4 minutes, with participants maintaining a constant pedal frequency (cadence ~90 rpm) until reaching LT. Visit 3: Baseline oral glucose tolerance test (OGTT)-Participants will be consumed 75 grams of glucose dissolved in water (Glucolin glucose powder) and blood samples will be collected to determine baseline glucose and insulin level. Visit 4: Attachment of Continuous Glucose Monitor (CGM) (FreeStyle Libre, Abbott Diabetes Care, Witney, UK) will be placed on the back of the upper arm as recommended by the manufacturer. Visit 5: Pre-exercise blood sampling-to determine plasma glucose, insulin and circulatory factors. Participants will be 60 minutes of cycling bouts at 90% of LT under simulated altitude exposure (normoxia or two hypoxic conditions) in the environmental chamber. Post-exercise blood sampling-2 hours OGTT will be performed immediately following each experimental trial to determine glucose homeostasis and circulatory factors. Visit 6: Post-exercise 24 hours blood sampling-to determine glucose homeostasis and circulatory factors. Removal of CGM

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Physical Inactivity, Healthy
Keywords
Hypoxia, Overweight, Glucose tolerance, Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will be required to complete 3 exercise interventions.
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate intensity exercise under normoxia
Arm Type
Placebo Comparator
Arm Description
The participants will perform low-moderate intensity cycling exercise at 90% lactate threshold (LT) (determined during LT test) under normoxia (FiO2: 20.9%) for 60 minutes on a cycle ergometer. Immediately after exercise oral glucose tolerance test (OGTT) will be determined with 24-hour glucose concentration will be monitored continuously. Circulatory factors will be determined pre, immediately after exercise and 24 hours after exercise.
Arm Title
Moderate intensity exercise under hypoxia
Arm Type
Experimental
Arm Description
The participants will perform low-moderate intensity cycling exercise at 90% lactate threshold (LT) (determined during LT test) under hypoxia (FiO2: 16.5-14.8%) for 60 minutes on a cycle ergometer. Immediately after exercise oral glucose tolerance test (OGTT) will be determined with 24-hour glucose concentration will be monitored continuously. Circulatory factors will be determined pre, immediately after exercise and 24 hours after exercise.
Intervention Type
Other
Intervention Name(s)
Low-moderate intensity exercise under normoxia
Intervention Description
The participant will perform the exercise interventions consisting of cycling at the 90% lactate threshold at normoxia (fraction oxygen: 20.9%) for 60 minutes on separate days (5-7 days). Immediately after exercise oral glucose tolerance test (OGTT) and 24-hour glucose concentration will be monitored continuously. Pre, post and post-24 h circulatory markers will be determined.
Intervention Type
Other
Intervention Name(s)
Low-moderate intensity exercise under moderate hypoxia
Intervention Description
The participant will perform the exercise interventions consisting of cycling at the 90% lactate threshold at normoxia (fraction oxygen: 16.5%) for 60 minutes on separate days (5-7 days). Immediately after exercise oral glucose tolerance test (OGTT) and 24-hour glucose concentration will be monitored continuously. Pre, post and post-24 h circulatory markers will be determined.
Intervention Type
Other
Intervention Name(s)
Low-moderate intensity exercise under high hypoxia
Intervention Description
The participant will perform the exercise interventions consisting of cycling at the 90% lactate threshold at normoxia (fraction oxygen: 14.8%) for 60 minutes on separate days (5-7 days). Immediately after exercise oral glucose tolerance test (OGTT) and 24-hour glucose concentration will be monitored continuously. Pre, post and post-24 h circulatory markers will be determined.
Primary Outcome Measure Information:
Title
Fasting and postprandial plasma glucose concentration
Description
Change of plasma glucose concentration immediately post-exercise under hypoxia (14.8-16.5% oxygen) compared to normoxia.
Time Frame
Change of fasting and postprandial plasma glucose concentrations (mmol/L) compared to moderate intensity exercise under normoxia (20.9% oxygen) at immediately after exercise (2 hour oral glucose tolerance test).
Title
Fasting and postprandial plasma insulin concentration
Description
Change of plasma insulin concentration immediately post-exercise under hypoxia (14.8-16.5% oxygen) compared to normoxia.
Time Frame
Change of fasting and postprandial plasma insulin concentrations (mU/L) compared to moderate intensity exercise under normoxia (20.9% oxygen) at immediately after exercise (2 hour oral glucose tolerance test).
Secondary Outcome Measure Information:
Title
Average 24 hours glucose concentration
Description
Glucose concentration will be measured in the interstitial fluid of the subcutaneous adipose tissue every 15 min using a glucose sensor (FreeStyle Libre, Abbott Diabetes Care, Witney, UK), which will be inserted subcutaneously, under skin on the arm, and will be connected to a continuous glucose monitor (Abbott FreeStyle Libre™). The cumulative effects of the acute single-bout exercise will be determined using the average 24 hours glucose levels collected on post 24 h.
Time Frame
Change of average glucose concentration compared to moderate intensity exercise under normoxia (20.9% oxygen) up to 24 hour after exercise.
Title
Circulating concentration of fibroblast growth factor 21 (FGF-21)
Description
Moderate intensity exercise under moderate-high hypoxia compared to normoxia. Pre, immediate post and post 24 hours blood will be sampled and analysed for circulating markers by means of ELISA
Time Frame
Change of concentrations of FGF-21 compared to moderate intensity exercise under normoxia (20.9% oxygen) immediately after exercise and at 24 hours after exercise.
Title
Circulating concentration of apelin
Description
Moderate intensity exercise under moderate-high hypoxia compared to normoxia. Pre, immediate post and post 24 hours blood will be sampled and analysed for circulating markers by means of ELISA
Time Frame
Change of concentrations of apelin compared to moderate intensity exercise under normoxia (20.9% oxygen)immediately after exercise and at 24 hours after exercise.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI is between 25-29 kg/m² Sedentary (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donny Camera, PhD
Organizational Affiliation
Swinburne University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Sports Institute of Malaysia
City
Kuala Lumpur
ZIP/Postal Code
57000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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The Potential of a Low Oxygen Environmental Chamber as an Aid to Exercise Training to Improve Metabolic Health

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