An interventional study of Polyglucosamine L112 and Placebo in Obesity, sponsored by Azienda di Servizi alla Persona di Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Azienda di Servizi alla Persona di Pavia · Not applicable, Interventional, and Treatment
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
3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's enrollment of 150 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Azienda di Servizi alla Persona di Pavia is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Excipients and gum arabic in tablet
Combination Product: Placebo
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)
Dietary Supplement: 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
excipients and gum arabic
Changes on anthropometric measures
Body weight (Kg)
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on lipid profile
Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)
Time frame: Changes from baseline lipid profile at 90 days
Changes on insulin resistance
Homeostasis Model Assessment (pt) for evaluate insulin resistance il \> 2,4
Time frame: Changes from baseline insulin resistance at 90 days
Changes on Carbohydrate profile
Glycemia (mg/dl)
Time frame: Changes from baseline Carbohydrate profile at 90 days
Changes on Carbohydrate profile
Insulin (mcU/ml)
Time frame: Changes from baseline Carbohydrate profile at 90 days
Changes on safety
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Time frame: Changes from baseline safety at 90 days
Changes on safety
Gamma glutamyl transferase (U/I)
Time frame: Changes from baseline safety at 90 days
Changes on safety
Creatinine (mg/dl)
Time frame: Changes from baseline safety at 90 days
Changes on anthropometric measures
Waist circumference (cm)
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on anthropometric measures
Body Mass Index (Kg/m2)
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on body composition
Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Time frame: Changes from baseline body composition at 90 days
Changes on oxidative stress
Reactive Oxygen Species (CARR U)
Time frame: Changes from baseline oxidative stress at 90 days
Changes on oxidative stress
Total Antioxidant Capacity (ORAC U)
Time frame: Changes from baseline oxidative stress at 90 days
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda di Servizi alla Persona di Pavia