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Completed

NCT Number: NCT05022732

Polyglucosamine L112 in Overweight and Obese Subjects

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

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Key information

Conditions

Obesity Body Weight Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyglucosamine L112

Dietary Supplement

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

Combination Product

excipients and gum arabic

Primary outcomes

  1. Changes on anthropometric measures

    Time frame: Changes from baseline anthropometric measures at 90 days

    Body weight (Kg)

Secondary outcomes

  1. Changes on lipid profile

    Time frame: Changes from baseline lipid profile at 90 days

    Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)

  2. Changes on insulin resistance

    Time frame: Changes from baseline insulin resistance at 90 days

    Homeostasis Model Assessment (pt) for evaluate insulin resistance il > 2,4

  3. Changes on Carbohydrate profile

    Time frame: Changes from baseline Carbohydrate profile at 90 days

    Glycemia (mg/dl)

  4. Changes on Carbohydrate profile

    Time frame: Changes from baseline Carbohydrate profile at 90 days

    Insulin (mcU/ml)

  5. Changes on safety

    Time frame: Changes from baseline safety at 90 days

    Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)

  6. Changes on safety

    Time frame: Changes from baseline safety at 90 days

    Gamma glutamyl transferase (U/I)

  7. Changes on safety

    Time frame: Changes from baseline safety at 90 days

    Creatinine (mg/dl)

  8. Changes on anthropometric measures

    Time frame: Changes from baseline anthropometric measures at 90 days

    Waist circumference (cm)

  9. Changes on anthropometric measures

    Time frame: Changes from baseline anthropometric measures at 90 days

    Body Mass Index (Kg/m2)

  10. Changes on body composition

    Time frame: Changes from baseline body composition at 90 days

    Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)

  11. Changes on oxidative stress

    Time frame: Changes from baseline oxidative stress at 90 days

    Reactive Oxygen Species (CARR U)

  12. Changes on oxidative stress

    Time frame: Changes from baseline oxidative stress at 90 days

    Total Antioxidant Capacity (ORAC U)

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device Based on Polyglucosamine L112® in a Group of Overweight and Obese Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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