NCT05627804

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 13, 2022

Last Update Submit

November 20, 2023

Conditions

OverweightHealthyPhysical Inactivity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Moderate hypoxia

EXPERIMENTAL

The participant will perform different exercise modes under moderate hypoxia (fraction oxygen: 16.5%). Blood samples immediately after exercise oral glucose tolerance test will be collected.

Other: Low-moderate intensity exerciseOther: Sprint interval trainingOther: Functional exercise

Control normoxia

OTHER

The participant will not perform any exercise under normoxia and moderate hypoxia. Blood samples of oral glucose tolerance test will be collected.

Other: Control

Interventions

Low-moderate intensity exerciseOTHER

The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia

Moderate hypoxia
Sprint interval trainingOTHER

The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.

Moderate hypoxia
Functional exerciseOTHER

The participants will perform bodyweight exercises under moderate hypoxia.

Moderate hypoxia
ControlOTHER

No exercise will be performed.

Control normoxia

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Impaired glucose tolerance (2 hour glucose: \>7.8 - 11.1 mmol/L)
  • Type 2 diabetes mellitus
  • Obstructive sleep apnea
  • Chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Sports Institute of Malaysia

Kuala Lumpur, 57000, Malaysia

Location

MeSH Terms

Conditions

OverweightSedentary Behavior

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 28, 2022

Study Start

January 3, 2023

Primary Completion

June 30, 2023

Study Completion

August 1, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

MY(1)