NCT05311800

Brief Summary

The aims of this study was to compare two isoenergetic HIIT (High-intensity Interval training) programs (cycling vs. running) on body composition, substrate oxidation at rest and during a moderate exercise, muscle functionality, glycaemic control, lipid profile, inflammation, maximal aerobic capacity (VO2max) and gut microbiota composition in men with overweight or obesity. The investigators hypothesized that both programs could decrease total, abdominal and visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and blood flow, and that running could favors greater fat mass losses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

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

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

March 16, 2022

Last Update Submit

February 22, 2023

Conditions

Keywords

cyclingrunninghigh-intensity interval trainingfat massvisceral tissuehealth

Outcome Measures

Primary Outcomes (2)

  • HIIT mode and fat mass change (g)

    change of total fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison

    At the first and the last training - week 1 and 12

  • HIIT mode and abdominal fat mass change (g)

    change of abdominal fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison

    At the first and the last training - week 1 and 12

Secondary Outcomes (1)

  • Rate of carbohydrate and lipid oxidation (g.min-1) during a sub-maximal exercise by measuring gaz exchange.

    At the first and the last training - week 1 and 12

Study Arms (2)

High intensity interval training - BIKE (HIIE BIKE)

EXPERIMENTAL

10 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s)

Other: Physical activity

High intensity interval training - RUN (HIIE RUN)

EXPERIMENTAL

9 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (35min15s)

Other: Physical activity

Interventions

Comparison of HIIT mode (running vs cycling)

High intensity interval training - BIKE (HIIE BIKE)High intensity interval training - RUN (HIIE RUN)

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men (18 to 65 years old)
  • with overweight or obesity (BMI \> 25 kg/m2 and ≤ 40 kg/m2)

You may not qualify if:

  • medical contraindications to intense physical activity,
  • painful joints,
  • taking ß-blocker

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

OverweightObesityMultiple Endocrine Neoplasia Type 1

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Data collected on the volunteers will be made anonymous.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups : running vs cycling
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 5, 2022

Study Start

September 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations