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Overweight (BMI > 25)NCT07196852

Redox Status and Exercise Training-induced Adaptations

A study testing N Acetyl L Cysteine in people with Overweight (BMI > 25) and Obesity, 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

Excess fat accumulation is a key feature of overweight and obesity that is mainly driven by nutrient overload and insufficient physical activity. White adipose tissue displays lipid overload and hypertrophy accompanied by macrophages infiltration, hypoxia, inflammation and excess production of reactive oxygen species… Read more about this study

Who is it for?
Ages 30 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Overweight (BMI > 25), Obesity
What is being tested?
N Acetyl L Cysteine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteGreece
Study dates
22 Sep 2025to 30 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI 25-35 kg/m2
  • Free of musculoskeletal injuries
  • Free of chronic non-communicable diseases
  • Do not receive any drug therapy
  • Do not receive dietary supplements
  • Normal menstrual cycle (for females)
  • Non smokers

Who cannot join

  • NAC intolerance
  • Bleeding disorders
  • Kidney disease
  • Asthma
  • Usage of blood thinners and/or angina medication

Trial locations and contacts

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

Dimitrios Draganidis, PhD contact

+30 2431047078

ddraganidis@uth.gr

Ioannis G. Fatouros, PhD contact

+30 2431047047

ifatouros@uth.gr

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

    Trikala, Karies, 42100

    Dimitrios Draganidis, PhD, +30 2431047078, ddraganidis@uth.gr

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

    Recruiting

Other trials in Greece

About this study

Official title: Effects of N-acetylcysteine on Biological Responses to High-intensity Interval Training in Adults With Overweight/Obesity

Excess fat accumulation is a key feature of overweight and obesity that is mainly driven by nutrient overload and insufficient physical activity. White adipose tissue displays lipid overload and hypertrophy accompanied by macrophages infiltration, hypoxia, inflammation and excess production of reactive oxygen species (ROS). An inflammatory response and ROS production are also evident in other metabolism regulating tissues and organs such as skeletal muscle, liver, pancreas and hypothalamus, contributing to a chronic inflammatory state, redox status disturbances and metabolic complications. There is overwhelming evidence showing that adults with overweight/obesity exhibit lower glutathione (GSH) levels in blood erythrocytes, skeletal muscle cells and subcutaneous and visceral adipose tissue cells. GSH, a tripeptide consisting of the amino acids glutamate, cysteine and glycine, is the most abundant thiol-containing antioxidant in the human body and has been, recently, characterized as a novel therapeutic target for the treatment of numerous chronic diseases, due to its potent intracellular redox buffering capacity. Interestingly, lower GSH levels have been associated with diet-induced weight loss resistance, while enhancement of GSH levels through N-acetylcysteine (NAC) supplementation reduces markers of oxidative stress, inflammation, insulin resistance, hypertension, endothelia dysfunction and improves vitamin D metabolism. NAC is a thiol donor that elicits antioxidant effects by (i) directly scavenging ROS and (ii) providing reduced cysteine through deacetylation, which supports the biosynthesis of endogenous GSH via the activity of γ-glutamylcysteine synthase. The aim of this study is to investigate whether NAC supplementation can enhance the exercise training-induced improvements on physical fitness and metabolic health in adult men and women with overweight/obesity.

Read the detailed description

Forty adults with overweight/obesity (both males and females, aged 35-45 years) who will meet the inclusion criteria will be randomly assigned to a Placebo (Pla, n=20, will be supplemented with 2 placebo pills daily over a 12-week period) or a NAC (NAC, n=20 will be supplemented with 2 pills x 600 mg N-acetylcysteine daily over a 12-week period) group. Both groups will participate in 3 multicomponent high-intensity interval training (m-HIIT) sessions per week over a 12-week period. At baseline, 6 weeks and 12 weeks participants will undergo assessment of their (i) anthropometrics (body weight, waist and hip circumferences) (ii) body composition (through total body DXA scan), (iii) fat liver content (via high-resolution ultrasound), (iv) cardiorespiratory fitness (determination of VO2max), (v) muscle strength (upper and lower body), (vi) habitual physical activity level (via accelerometry) and (vii) daily dietary intake (via dietary recalls). In addition, at the same time-points (Baseline, 6 weeks, 12 weeks), resting blood samples will be collected for the determination of (viii) blood redox status [reduced glutathione (GSH), oxidized glutathione (GSSH), GSH/GSSG, glutathione peroxidase (GPx), glutathione reductase (GR), superoxide dismutase (SOD) and catalase (CAT)], (ix) peripheral blood mononuclear cells antioxidant levels and markers of oxidative stress and inflammation (catalase, superoxide dismutase, glutathione peroxidase, glutathione reductase, malondialdehyde, TNF-α and Interleukin-6), (x) low-grade systemic inflammation [C-reactive protein (CRP) and Interleukin-6 (IL-6)], (xi) lipidemic profile (triglycerides, total cholesterol, HDL, LDL) and (xii) liver function (SGPT, SGOT, γ-GT, ALP, Fetuin-A), and (xiii) an oral glucose tolerance test (using 75g glucose loading) will be performed.

Being tested
N Acetyl L Cysteine, Placebo
Keywords
overweight, obesity, N-acetylcysteine, high-intensity interval training
Medical subject headings
Overweight, Obesity

What participants receive

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

  • N Acetyl L CysteineDietary supplement

    Participants will participate in 3 multicomponent high-intensity interval training (m-HIIT) sessions per week over a 12-week period while receiving daily 1200 mg N-acetylcysteine (2 pills x 600 mg/day ).

  • PlaceboDietary supplement

    Participants will participate in 3 multicomponent high-intensity interval training (m-HIIT) sessions per week over a 12-week period while receiving daily 2 placebo pills/day.

Study groups in NCT07196852
Study groupRoleWhat they receive
N-acetylcysteineExperimentalOral N-acetylcysteine supplementation for 12 weeks (2 x 600 mg capsules/day)
Receives: Dietary Supplement: N Acetyl L Cysteine
PlaceboPlacebo comparatorOral placebo supplementation for 12 weeks (2 placebo capsules/day)
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Change in body weight (kg)

    Measured: At baseline, 6 weeks and 12 weeks

  2. Change in waist circumference

    Measured: At baseline, 6 weeks and 12 weeks

  3. Change in hip circumference

    Measured: At baseline, 6 weeks and 12 weeks

  4. Change in fat mass (kg)

    Fat mass will be assessed through dual energy X-ray absorptiometry (DXA)

    Measured: At baseline, 6 weeks and 12 weeks

  5. Change in body fat percent (%)

    Body fat percent will be assessed through dual energy X-ray absorptiometry (DXA)

    Measured: At baseline, 6 weeks and 12 weeks

  6. Change in fat free mass (kg)

    Fat free mass will be assessed through dual energy X-ray absorptiometry (DXA)

    Measured: At baseline, 6 weeks and 12 weeks

  7. Change in lean body mass (kg)

    Lean body mass will be assessed through dual energy X-ray absorptiometry (DXA)

    Measured: At baseline, 6 weeks and 12 weeks

  8. Change in liver fat infiltration

    Liver fat infiltration will be assessed through ultrasound elastography

    Measured: At baseline and 12 weeks

  9. Change in cardiorespiratory fitness

    Maximal oxygen consumption (VO2max) will be estimated during a single stage treadmill test (Ebbeling single stage test)

    Measured: At baseline, 6 weeks and 12 weeks

  10. Change in lower body muscle strength

    Maximal concentric peak torque will be assessed on an isokinetic dynamometer

    Measured: At baseline, 6 weeks and 12 weeks

  11. Change in upper body muscle strength

    Upper body muscle strength will be assessed through the abdominal strength test and the push-up test

    Measured: At baseline, 6 weeks and 12 weeks

  12. Change in reduced glutathione (GSH) concentration

    GSH concentration will be determined in blood erythrocytes and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  13. Change in oxidized glutathione (GSSG) concentration

    GSSG concentration will be determined in blood erythrocytes and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  14. Change in glutathione peroxidase (GPx) activity

    GPx activity will be determined in blood erythrocytes and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  15. Change in glutathione reductase (GR) activity

    GR activity will be determined in blood erythrocytes and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  16. Change in catalase activity

    Catalase activity will be determined in blood erythrocytes and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  17. Change in superoxide dismutase (SOD) activity

    SOD activity will be determined in blood erythrocytes and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  18. Change in malondialdehyde concentration

    Malondialdehyde concentration will be determined in peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  19. Change in C-reactive protein (CRP) concentration

    Measured: At baseline, 6 weeks and 12 weeks

  20. Change in TNF-α concentration

    TNF-α concentration will be determined in blood and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  21. Change in interleukin-6 (IL-6) concentration

    IL-6 concentration will be determined in blood and peripheral blood mononuclear cells

    Measured: At baseline, 6 weeks and 12 weeks

  22. Change in HDL cholesterol concentration

    HDL cholesterol concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  23. Change in LDL cholesterol concentration

    LDL cholesterol concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  24. Change in total cholesterol concentration

    Total cholesterol concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  25. Change in triglycerides concentration

    Triglycerides concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  26. Change in serum glutamic-oxaloacetic transaminase (SGOT/AST) concentration

    SGOT concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  27. Alanine Aminotransferase (SGPT/ALT) concentration

    SGPT concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  28. Change in Gamma-glutamyl transpeptidase (γ-GT) concentration

    γ-GT concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  29. Change in fetuin-A concentration

    Fetuin-A concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  30. Change in alkaline phosphatase (ALP) concentration

    ALP concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  31. Change in glucose concentration

    Glucose concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  32. Change in glycated hemoglobin (HbA1c) concentration

    HbA1c concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

  33. Change in insulin concentration

    Insulin concentration will be determined in blood

    Measured: At baseline, 6 weeks and 12 weeks

Secondary outcomes (3)
  1. Change in dietary intake

    Dietary intake will be monitored through diet recalls

    Measured: At baseline, 6 weeks and 12 weeks

  2. Change in total number of steps

    Total number of steps performed per day will be assessed by using accelerometers

    Measured: At baseline, 6 weeks and 12 weeks

  3. Change in time spent in moderate-to-vigorous physical activity

    The time spent in moderate-to-vigorous physical activity per day will be assessed by using accelerometers

    Measured: At baseline, 6 weeks and 12 weeks

Timeline

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

  1. First posted29 Sep 2025
  2. Study start22 Sep 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial with repeated measures
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07196852
Sponsor's protocol ID
UTH-2568_2.4.2025
Status last verified
Dec 2025
First submitted
19 Sep 2025
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing N Acetyl L Cysteine in people with Overweight (BMI > 25) and Obesity, 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 7 inclusion and 5 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 16 Dec 2025. 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. Some participants in this study may receive a placebo. 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 Dimitrios Draganidis, PhD (+30 2431047078, ddraganidis@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (kg) (time frame: At baseline, 6 weeks and 12 weeks). The study lists 33 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 16 Dec 2025.

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