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Obesity & OverweightNCT07341711

Long-term Adaptations of Skeletal Muscle After Hybrid Training

A study testing Exercise training in people with Obesity & Overweight, run by University of Thessaly at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Obesity & Overweight
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGreece
Study dates
8 Jan 2026to 20 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • Free of non-communicable diseases (excluding metabolic syndrome)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ioannis G Fatouros, Professor contact

24310 47047 ext. 0030

ifatouros@pe.uth.gr

Greece1 site, 1 recruiting
  • Department of Physical Education and Sport Science Trikala, University of Thessaly

    Trikala, Thessaly, 42100

    Ioannis G Fatouros, Professor, +30 2431047047, ifatouros@uth.gr

    Athanasios Z Jamurtas, Professor, +30 2431047054, ajamurt@uth.gr

    Recruiting

Other trials in Greece

About this study

Official title: Long-term Adaptations of Skeletal Muscle in Overweight and Obese Individuals After Hybrid Training

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.

Read the detailed description

A total number of 30 adults (both males and females) aged 30-50, meeting the inclusion criteria, will be enrolled in this study. Participants will be randomly assigned to either (i) a Control group or (ii) an Intervention group. The Intervention group will participate in three hybrid-type HIIT sessions per week over a 6-month period while receiving a balanced diet. The Control group will receive a balanced diet over the 6-month period but will not participate in exercise training. At baseline and 6 months, both groups will undergo assessment of their anthropometric profile, body composition, resting metabolic rate, muscle strength and cardiorespiratory capacity and provide resting blood and skeletal muscle samples.

Being tested
Exercise training, Control group
Keywords
obesity, overweight, high-intensity interval training, skeletal muscle
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise trainingOther

    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.

  • Control groupOther

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

Study groups in NCT07341711
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in this arm will participate in three hybrid-type HIIT sessions per week over a 6-month period while receiving a balanced diet
Receives: Other: Exercise training
Control groupActive comparatorParticipants in this arm will receive a balanced diet over the 6-month period but will not participate in exercise training
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mitochondrial size

    Mitochondrial size will be measured using transmission electron microscope

    Measured: At baseline and at 6 months

  2. Change in mitochondrial density

    Mitochondrial density will be measured using transmission electron microscope

    Measured: At baseline and at 6 months

  3. Change in mitochondrial count

    Mitochondrial count will be determined using transmission electron microscope

    Measured: At baseline and at 6 months

  4. Change in mitochondrial distribution

    Mitochondrial distribution will be determined using transmission electron microscope

    Measured: At baseline and at 6 months

  5. 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

    Measured: At baseline and at 6 months

  6. Change in muscle fiber cross-sectional area

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

    Measured: At baseline and at 6 months

  7. Change in PAX7+ satellite cells count

    PAX7+ satellite cells will be determined using immunohistochemistry techniques.

    Measured: At baseline and at 6 months

  8. 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

    Measured: At baseline and at 6 months

  9. Change in myonuclei content

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

    Measured: At baseline and at 6 months

  10. 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.

    Measured: At baseline and at 6 months

  11. Change in Krebs cycle (TCA cycle) enzymes activity

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

    Measured: At baseline and at 6 months

  12. Change in protein expression of respiratory chain complexes

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

    Measured: At baseline and at 6 months

  13. Change in cytochrome C oxidase amount and expression

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

    Measured: At baseline and at 6 months

  14. Change in ATP synthase amount and expression

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

    Measured: At baseline and at 6 months

  15. Change in citrate synthase amount and expression

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

    Measured: At baseline and at 6 months

  16. Change in succinate dehydrogenase amount and expression

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

    Measured: At baseline and at 6 months

  17. Change in NADH dehydrogenase amount and expression

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

    Measured: At baseline and at 6 months

  18. Change in mitochondrial oxygen consumption rate

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

    Measured: At baseline and at 6 months

  19. Change in spare respiratory capacity

    Spare respiratory capacity will be determined using the Seahorse XF Analyzer

    Measured: At baseline and at 6 months

  20. Change in mitochondrial maximal respiration

    Maximal mitochondrial respiration will be determined using the Seahorse XF Analyzer

    Measured: At baseline and at 6 months

  21. Change in mitochondrial basal respiration

    Mitochondrial basal respiration will be determined using the Seahorse XF Analyzer

    Measured: At baseline and at 6 months

  22. Change in non-mitochondrial respiration

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

    Measured: At baseline and at 6 months

  23. Change in body fat percentage

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

    Measured: At baseline and at 6 months

  24. Change in diastolic arterial pressure

    Diastolic blood pressure will be measured using a sphygmomanometer

    Measured: At baseline and at 6 months

Secondary outcomes (30)
  1. Change in density and distribution of capillaries

    Capillarization will be determined using immunohistochemistry techniques

    Measured: At baseline and at 6 months

  2. Change in skeletal muscle fiber typing

    Fiber typing will be determined using immunohistochemistry techniques

    Measured: At baseline and at 6 months

  3. Change in GLUT-4 protein expression

    GLUT-4 protein expression will be assessed using immunoblotting techniques

    Measured: At baseline and at 6 months

  4. Change reduced glutathione content in skeletal muscle cells

    Reduced glutathione content will be determined spectrophotometrically

    Measured: At baseline and at 6 months

  5. Change in glutathione peroxidase activity in skeletal muscle cells

    Glutathione peroxidase activity will be determined spectrophotometrically

    Measured: At baseline and at 6 months

  6. Change in glutathione reductase activity in skeletal muscle cells

    Glutathione reductase activity will be determined spectrophotometrically

    Measured: At baseline and at 6 months

  7. Change in superoxide dismutase activity in skeletal muscle cells

    Superoxide dismutase activity will be determined spectrophotometrically

    Measured: At baseline and at 6 months

  8. Change in fasting glucose levels

    Fasting glucose levels will be measured on an automated clinical chemistry analyzer

    Measured: At baseline and at 6 months

  9. Change in fasting insulin levels

    Fasting insulin levels will be measured on an automated clinical chemistry analyzer

    Measured: At baseline and at 6 months

  10. Change in glycosylated hemoglobin levels

    Glycosylated hemoglobin levels will be measured on an automated clinical chemistry analyzer

    Measured: At baseline and at 6 months

  11. Change in high-density lipoprotein (HDL) levels

    HDL will be measured on an automated clinical chemistry analyzer

    Measured: At baseline and at 6 months

  12. Change in low-density lipoprotein (LDL) levels

    LDL will be measured on an automated clinical chemistry analyzer

    Measured: At baseline and at 6 months

  13. Change in total cholesterol levels

    Total cholesterol will be measured on an automated clinical chemistry analyzer

    Measured: At baseline and at 6 months

  14. Change in triglyceride levels

    Triglycerides will be measured on an automated clinical chemistry analyzer

    Measured: At baseline and at 6 months

  15. Change in general blood count

    General blood count will be measured on a hematology analyzer

    Measured: At baseline and at 6 months

  16. Change in erythrocyte reduced glutathione (GSH) levels

    Erythrocyte GSH levels will be determined spectrophotometrically

    Measured: At baseline and at 6 months

  17. Change in erythrocyte oxidized glutathione (GSSG) levels

    Erythrocyte GSSG levels will be determined spectrophotometrically

    Measured: At baseline and at 6 months

  18. Change in myostatin expression

    Myostatin expression will be assessed using immunoblotting techniques

    Measured: At baseline and at 6 months

  19. Change cortisol concentration

    Blood cortisol concentration will be assessed using immunoassays (ELISA)

    Measured: At baseline and at 6 months

  20. Change in testosterone concentration

    Blood testosterone concentration will be assessed using immunoassays (ELISA)

    Measured: At baseline and at 6 months

  21. Change in growth hormone concentration

    Blood growth hormone concentration will be assessed using immunoassays (ELISA)

    Measured: At baseline and at 6 months

  22. Change in insulin-like growth factor-1 (IGF-1) concentration

    Blood IGF-1 concentration will be assessed using immunoassays (ELISA)

    Measured: At baseline and at 6 months

  23. Change in body mass

    Body mass will be measured on a beam scale

    Measured: At baseline and at 6 months

  24. Change in bone density

    Bone density will be assessed using dual energy x-ray absorptiometry (DEXA)

    Measured: At baseline and at 6 months

  25. Change in fat-free mass

    Fat-free mass will be assessed using dual energy x-ray absorptiometry (DEXA)

    Measured: At baseline and at 6 months

  26. Change in waist circumference

    Waist circumference will be measured using a Gullick II tape

    Measured: At baseline and at 6 months

  27. Change in hip circumference

    Hip circumference will be measured using a Gullick II tape

    Measured: At baseline and at 6 months

  28. Change in resting heart rate

    Heart rate will be measured using a heart rate monitor

    Measured: At baseline and at 6 months

  29. Change in resting metabolic rate (RMR)

    RMR will be measured using indirect calorimetry

    Measured: At baseline and at 6 months

  30. Change in systolic arterial pressure

    Systolic blood pressure will be measured using a sphygmomanometer

    Measured: At baseline and at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start8 Jan 2026
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07341711
Sponsor's protocol ID
2482/4.12.2024
Status last verified
Oct 2025
First submitted
5 Jan 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Obesity & Overweight, run by University of Thessaly at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ioannis G Fatouros, Professor (24310 47047 ext. 0030, ifatouros@pe.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mitochondrial size (time frame: At baseline and at 6 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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