Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT05807204
Eligibility Criteria:
Inclusion Criteria:
* Men older than 40 years.
* BMI ≥30.0 kg/m\^2 and ≤35.0 kg/m\^2
* Waist circumference ≥102 cm.
* Read, write and speak Catalan or Spanish.
* Sign the informed consent.
Exclusion Criteria:
* Present values of body mass index \> 35 kg/m\^2
* Present values of waist circumference \> 150 cm.
* Present diabetes.
* Present dyslipidemia (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
* Present anemia.
* Taking supplements, multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.
* Consume 4 or more Standard Beverage Units (SBU) daily or 28 SBU weekly.
* Be a smoker.
* Present any diagnosed liver disease other than NAFLD.
* Have lost more than 3 kg of weight in the last 3 months.
* Present food intolerances and/or allergies related to the study products, such as hypersensitivity to maltodextrin or N-Acetylcysteine.
* Presenting any chronic or autoimmune disease in clinical manifestation such as hepatitis, hyper or hypothyroidism or metabolic diseases.
* Follow a pharmacological treatment with immunosuppressants, cytotoxic agents, corticosteroids or other drugs that could cause hepatic steatosis or alter the measurements in the liver.
* Being participating or having participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
* Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
* Suffering from eating behavior disorders or psychiatric disorders.
* Being unable to follow study guidelines.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT05807204
Study Brief:
Protocol Section:
NCT05807204