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The purpose of the study is to evaluate the effect 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/m2 being administered with a 3 g/day polyglucosamine dosage.
The primary objective of the study is to evaluate the effect 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/m2 being administered with a 3 g/day polyglucosamine dosage.
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product | Experimental | 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg |
|
| Placebo | Placebo Comparator | 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyglucosamine L112 | Drug | Polyglucosamine; Ascorbic Acid; Tartaric Acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG) | 3-month treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | To evaluate the effect of PG administration on triglycerides plasma levels | 3-month treatment |
| Cholesterol | To evaluate the effect of PG administration on total cholesterol plasma levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariangela Rondanelli, Prof. | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia | Pavia | Lombardy | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40898346 | Derived | Rondanelli M, Perna S, Porta MD, Lombardoni F, Patelli Z, Nichetti M, Gasparri C, Pistolesi E, Cestaro B, Cazzola R. Modification of metabolic syndrome parameters following the administration of polyglucosamine L112: results of a subgroup analysis of subjects enrolled in a double blind randomised placebo controlled clinical investigation. BMC Nutr. 2025 Sep 2;11(1):170. doi: 10.1186/s40795-025-01153-8. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Other | Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide |
|
| 3-month treatment |
| HOMA | To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA | 3-month treatment |
| Hepatic Enzymes - Renal Functionality | To evaluate the effect of PG administration on transaminases and creatinine | 3-month treatment |
| BMI | To evaluate the effect of PG administration on BMI | 3-month treatment |
| Abdominal Circumference | To evaluate the effect of PG administration on the abdominal circumference | 3-month treatment |
| DXA | To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry) | 3-month treatment |
| ROS | To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels | 3-month treatment |
| Antioxidant Serum Capacity | To evaluate the effect of PG administration on serum antioxidant capacity | 3-month treatment |