Study Results
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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COMPLETED
NA
150 participants
INTERVENTIONAL
2020-05-05
2021-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control formula
Excipients and gum arabic in tablet
Placebo
excipients and gum arabic
Experimental formula
Polyglucosamine L112 (750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients)
Polyglucosamine L112
750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients
Interventions
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Polyglucosamine L112
750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients
Placebo
excipients and gum arabic
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Azienda di Servizi alla Persona di Pavia
OTHER
Responsible Party
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Principal Investigators
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Mariangela Rondanelli
Role: PRINCIPAL_INVESTIGATOR
Fondazione Casemiro Mondino
Locations
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Azienda di Servizi alla Persona
Pavia, , Italy
Countries
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Other Identifiers
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20200037586
Identifier Type: -
Identifier Source: org_study_id
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