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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT05022732
Eligibility Criteria:
Inclusion Criteria:
* weight \> 75 Kg
* absence of previous diet therapy attempts
* no fluctuation of at least 3 kg in the previous 3 months
* Beck Depression Inventory score \< 20 pt
* Binge Eating Scale score \< 27 pt
Exclusion Criteria:
* allergy to shellfish
* pregnancy or breast feeding
* presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System
* presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease
* symptomatic cholelithiasis
* previous or current neoplasms
* epilepsy
* obesity secondary to endocrinopathies or genetic syndromes
* significant motor disability or mental retardation
* major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), schizophrenia
* previous history or current diagnosis of drug abuse or alcoholism
* changing in smoking habits or quitting smoking in the last 6 months
* current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05022732
Study Brief:
Protocol Section:
NCT05022732