Polyglucosamine L112 in Overweight and Obese Subjects

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Obesity

Treatments: Combination Product: Placebo; Dietary Supplement: Polyglucosamine L112

Study type: Interventional

Funder types: Other

Identifiers

NCT05022732

20200037586

Details and patient eligibility

About

This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 kg / m2). and with weight> 75 kg

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Control formula

Placebo Comparator group

Description:

Excipients and gum arabic in tablet

Treatment:

Combination Product: Placebo

Experimental formula

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Polyglucosamine L112