NCT07341711

Brief Summary

Obesity is a major challenge for public health and renders it imperative to reduce its prevalence. High intensity interval training (HIIT) is a form of exercise training that can efficiently induce weight loss in adults with overweight or obesity, even in the absence of dietary intake manipulation. Hybrid type training represents a form of HIIT, that incorporates both cardiorespiratory and musculoskeletal stimuli, by combining multiple types of exercise into a circuit-type, interval style workout. Recent evidence suggests that long-term participation in hybrid HIIT results in significant health-related benefits. However, the molecular mechanisms driving the chronic effects of hybrid HIIT on cardiometabolic and musculoskeletal health remains to be elucidated.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

January 14, 2026

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Keywords

obesityoverweighthigh-intensity interval trainingskeletal muscle

Outcome Measures

Primary Outcomes (24)

  • Change in mitochondrial size

    Mitochondrial size will be measured using transmission electron microscope

    At baseline and at 6 months

  • Change in mitochondrial density

    Mitochondrial density will be measured using transmission electron microscope

    At baseline and at 6 months

  • Change in mitochondrial count

    Mitochondrial count will be determined using transmission electron microscope

    At baseline and at 6 months

  • Change in mitochondrial distribution

    Mitochondrial distribution will be determined using transmission electron microscope

    At baseline and at 6 months

  • Change in maximum oxygen consumption (VO2max)

    Maximum oxygen consumption (VO2max) will be assessed during a cardiopulmonary exercise testing by using a portable indirect calorimetry system

    At baseline and at 6 months

  • Change in muscle fiber cross-sectional area

    Muscle fiber cross-sectional area (μm2) will be measured using immunohistochemical staining for myosin heavy chain

    At baseline and at 6 months

  • Change in PAX7+ satellite cells count

    PAX7+ satellite cells will be determined using immunohistochemistry techniques.

    At baseline and at 6 months

  • Change in total protein content

    Total protein content (total RNA) will be determined in skeletal muscle tissue using real time quantitative-Polymerase Chain Reaction (q-PCR) technique

    At baseline and at 6 months

  • Change in myonuclei content

    Myonuclei content will be determined in skeletal muscle tissue using immunohistochemistry techniques

    At baseline and at 6 months

  • Change in peroxisome proliferator-activated receptor-gamma coactivator -1a (PGC-1a) expression

    PGC-1a expression in skeletal muscle tissue will be assessed using immunoblotting techniques.

    At baseline and at 6 months

  • Change in Krebs cycle (TCA cycle) enzymes activity

    Krebs cycle enzymes activity will be determined using the Seahorse XF Analyzer

    At baseline and at 6 months

  • Change in protein expression of respiratory chain complexes

    Protein expression of respiratory chain complexes will be determined using immunoblotting techniques

    At baseline and at 6 months

  • Change in cytochrome C oxidase amount and expression

    Cytochrome C oxidase amount and expression will be assessed using immunohistochemistry and immunoblotting techniques

    At baseline and at 6 months

  • Change in ATP synthase amount and expression

    ATP synthase amount and expression will be assessed using immunohistochemistry and immunoblotting techniques

    At baseline and at 6 months

  • Change in citrate synthase amount and expression

    Citrate synthase amount and expression will be assessed using immunohistochemistry and immunoblotting techniques

    At baseline and at 6 months

  • Change in succinate dehydrogenase amount and expression

    Succinate dehydrogenase amount and expression will be assessed using immunohistochemistry and immunoblotting techniques

    At baseline and at 6 months

  • Change in NADH dehydrogenase amount and expression

    NADH dehydrogenase amount and expression will be assessed using immunohistochemistry and immunoblotting techniques

    At baseline and at 6 months

  • Change in mitochondrial oxygen consumption rate

    Mitochondrial oxygen consumption rate will be determined using the Seahorse XF Analyzer

    At baseline and at 6 months

  • Change in spare respiratory capacity

    Spare respiratory capacity will be determined using the Seahorse XF Analyzer

    At baseline and at 6 months

  • Change in mitochondrial maximal respiration

    Maximal mitochondrial respiration will be determined using the Seahorse XF Analyzer

    At baseline and at 6 months

  • Change in mitochondrial basal respiration

    Mitochondrial basal respiration will be determined using the Seahorse XF Analyzer

    At baseline and at 6 months

  • Change in non-mitochondrial respiration

    Non-mitochondrial respiration will be determined using the Seahorse XF Analyzer

    At baseline and at 6 months

  • Change in body fat percentage

    Body fat percentage will be assessed using dual energy x-ray absorptiometry (DEXA)

    At baseline and at 6 months

  • Change in diastolic arterial pressure

    Diastolic blood pressure will be measured using a sphygmomanometer

    At baseline and at 6 months

Secondary Outcomes (30)

  • Change in density and distribution of capillaries

    At baseline and at 6 months

  • Change in skeletal muscle fiber typing

    At baseline and at 6 months

  • Change in GLUT-4 protein expression

    At baseline and at 6 months

  • Change reduced glutathione content in skeletal muscle cells

    At baseline and at 6 months

  • Change in glutathione peroxidase activity in skeletal muscle cells

    At baseline and at 6 months

  • +25 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in this arm will participate in three hybrid-type HIIT sessions per week over a 6-month period while receiving a balanced diet

Other: Exercise training

Control group

ACTIVE COMPARATOR

Participants in this arm will receive a balanced diet over the 6-month period but will not participate in exercise training

Other: Control group

Interventions

Participants will perform a six-month hybrid training program while receiving a balanced diet. The periodization of hybrid training intervention will consist of three 2-month phases of gradually increased exercise intensity and volume. In every training will participate 5-8 individuals. The training will contain 6-12 different exercises (stations), depending on the phase of the intervention, which will be executed in a circuit for a total of 2-3 rounds, with 2-3 minutes of rest period between sets (depending on the phase). The exercise execution will last 20-45 seconds, and the rest between them will last 30-60 seconds (depending on the phase), while the exercise intensity will range from 75 to 85% of maximal heart rate. The stations of hybrid training will contain multi-joint exercises or neuromuscular activation exercises using either body weight resistance or portable equipment.

Intervention group

Participants will receive a balanced diet but will not participate in any type of exercise training over a six month period.

Control group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: \>25 kg/m2 and \<40 kg/m2
  • Untrained individuals (abstain \>1 year from exercise training)
  • No dietary intervention over the last 6 months preceding the study
  • Low cardiorespiratory fitness level (VO2max: \<45 ml/kg/min)
  • No use of any medication, dietary supplements
  • Low risk for cardiovascular disease
  • A weight loss \<10% over the last 6 months preceding the study
  • Fee of non-communicable diseases (excluding metabolic syndrome)

You may not qualify if:

  • Low participation rate (\<80% completion of the exercise training sessions)
  • Unbalanced diet
  • Participation in additional exercise training regimes
  • Cosumption of anti-inflammatory of pain relief medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport Science Trikala, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

ExerciseControl Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Ioannis G Fatouros, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

January 8, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

January 14, 2026

Record last verified: 2025-10

Locations