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Redox Status and Exercise Training-induced Adaptations

NCT ID: NCT07196852

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight (BMI > 25) Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial with repeated measures
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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N-acetylcysteine

Oral N-acetylcysteine supplementation for 12 weeks (2 x 600 mg capsules/day)

Group Type EXPERIMENTAL

N Acetyl L Cysteine

Intervention Type DIETARY_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 ).

Placebo

Oral placebo supplementation for 12 weeks (2 placebo capsules/day)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_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.

Interventions

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N Acetyl L Cysteine

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 ).

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* NAC intolerance
* Bleeding disorders
* Kidney disease
* Asthma
* Usage of blood thinners and/or angina medication
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Dimitrios Draganidis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anastasia Rosvoglou, PhDc

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly, Department of Physical Education and Sport Science

Dimitrios Draganidis, PhD

Role: STUDY_DIRECTOR

University of Thessaly, Department of Physical Education and Sport Science

Locations

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Department of Physical Education and Sport Science, University of Thessaly

Trikala, Karies, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Dimitrios Draganidis, PhD

Role: CONTACT

[email protected]
+30 2431047078

Ioannis G. Fatouros, PhD

Role: CONTACT

[email protected]
+30 2431047047

Facility Contacts

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Dimitrios Draganidis, PhD

Role: primary

[email protected]
+30 2431047078

Ioannis G. Fatouros, PhD

Role: backup

[email protected]
+30 2431047047

Other Identifiers

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UTH-2568_2.4.2025

Identifier Type: -

Identifier Source: org_study_id