Clinical trial

Redox Status and Exercise Training-induced Adaptations

Recruiting now · Not applicable · 1 countries · Registry ID NCT07196852

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 45 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight (BMI > 25), Obesity

Full registry criteria

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

Treatments and study arms

N Acetyl L Cysteine

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

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.

Primary outcomes

Change in body weight (kg)At baseline, 6 weeks and 12 weeks

Change in waist circumferenceAt baseline, 6 weeks and 12 weeks

Change in hip circumferenceAt baseline, 6 weeks and 12 weeks

Change in fat mass (kg)At baseline, 6 weeks and 12 weeks

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

Change in body fat percent (%)At baseline, 6 weeks and 12 weeks

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

Change in fat free mass (kg)At baseline, 6 weeks and 12 weeks

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

Change in lean body mass (kg)At baseline, 6 weeks and 12 weeks

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

Change in liver fat infiltrationAt baseline and 12 weeks

Liver fat infiltration will be assessed through ultrasound elastography

Study locations

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Department of Physical Education and Sport Science, University of Thessaly🇬🇷 Trikala, Karies, Greece

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Dimitrios Draganidis, PhDContact

Email · Call +30 2431047078

Ioannis G. Fatouros, PhDContact

Email · Call +30 2431047047