NCT07814599

Brief Summary

Obesity management involves lifestyle and dietary measures that include appropriate nutrition and increased physical activity (PA). Among the various PA options available, HIIT (High-Intensity Interval Training) workouts are now recognized as fun and effective programs for promoting fat loss. To date, in overweight or obese individuals, only two studies mention the benefits of HIIT performed under hypoxia for modulating body composition, and more specifically, reducing the amount of adipose tissue. These studies hypothesize an increased energy expenditure under hypoxia associated with a transient loss of appetite. In order, to further investigate the adaptations following HIIT under hypoxia versus normoxia, we propose to compare, in acute conditions, two HIIT sessions (simulated hypoxia-normobaric vs. normoxia) in overweight or obese subjects. The objective of this assessment is to compare, during exercise and recovery (+2h), oxygen consumption, corresponding energy expenditure, and carbohydrate and lipid utilization in hypoxic versus normoxic conditions. Given the potential influence of hypoxia on appetite, spontaneous food intake and energy expenditure post-24h will also be measured. Finally, since pleasure and perceived exertion are key parameters in adherence to an adapted physical activity (APA) program, these two concepts will also be evaluated through the subjects' experiences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Typical duration 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

Study Start

First participant enrolled

November 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.8 years

First QC Date

September 5, 2026

Last Update Submit

September 5, 2026

Conditions

Keywords

high intensity interval exercisehypoxiasubstrate oxidationappetiteenergy intake

Outcome Measures

Primary Outcomes (1)

  • Lipid oxidation after the exercise session (nromoxia and hypoxia).

    Determination of lipid and carbohydrate oxidation after the exercise (HIIE normoxia and hypoxia). Lipid aoxidation is measured from oxygen and carbon dioxide consumption (Metamax 3D Cortex).

    Measurement during two hours after the end of the exercise

Secondary Outcomes (3)

  • Oxygen consumption during the recovery period

    Two hours after the end of the exercise

  • Energy intakes 24 hours after the exercise

    24 hours post exercise

  • Appetite

    Before exercise and after exercise (+0 min, +60 min, and +120 min).

Study Arms (2)

High Intensity Interval Exercise - Normoxia

EXPERIMENTAL

HIIE in normoxia

Other: HIIE - Normoxia

High Intensity Interval Exercise - Hypoxia

EXPERIMENTAL

HIIE in hypoxia

Other: HIIE - Hypoxia

Interventions

Cycling HIIE in Normoxia: 60 x \[8 seconds at a power equivalent to 80-85% of HRmax followed by 12 seconds of active recovery at a power equivalent to 40% of HRmax\]

High Intensity Interval Exercise - Normoxia

Cycling HIIE in Hypoxia (FiO2: 15%): 60 x \[8 seconds at a power equivalent to 80-85% of HRmax followed by 12 seconds of active recovery at a power equivalent to 40% of HRmax\]

High Intensity Interval Exercise - Hypoxia

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- overweight or obesity (BMI between 25 kg/m2 and 35 kg/m2)

You may not qualify if:

  • medical contraindications to intense physical activity
  • taking ß-blocker
  • diabete
  • women taking hormonal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CREPS Auvergne Rhône-Alpes / Vichy

Bellerive-sur-Allier, Allier, 03321, France

Location

MeSH Terms

Conditions

ObesityOverweightHypoxia

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Respiratory

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Data collected on the volunteers will be made anonymous.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2026

First Posted

September 11, 2026

Study Start

November 1, 2024

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

September 11, 2026

Record last verified: 2026-09

Locations