NCT04375696

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

April 30, 2020

Last Update Submit

November 17, 2022

Conditions

Weight Loss

Keywords

PolyglucosamineFormoline L112Medical Device

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)

    3-month treatment

Secondary Outcomes (9)

  • Triglycerides

    3-month treatment

  • Cholesterol

    3-month treatment

  • HOMA

    3-month treatment

  • Hepatic Enzymes - Renal Functionality

    3-month treatment

  • BMI

    3-month treatment

  • +4 more secondary outcomes

Study Arms (2)

Product

EXPERIMENTAL

75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg

Drug: Polyglucosamine L112

Placebo

PLACEBO COMPARATOR

75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg

Other: Placebo

Interventions

Polyglucosamine L112DRUG

Polyglucosamine; Ascorbic Acid; Tartaric Acid

Also known as: Formoline L112
Product
PlaceboOTHER

Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Age between 18-65
  • Both sexes - mandatory adequate contraceptive method for women in fertility age
  • BMI between 25-32 kg/m2 and weigh in \> 75 kg, with no previous diet-therapy attempts with at least a 5% weight loss in the last year
  • No 3 kg weight fluctuation in the last 3 months
  • Beck Depression Inventory (BDI) score \< 20
  • Binge Eating Scale (BES) score \< 27

You may not qualify if:

  • Shellfish allergy or to any other ingredient in the product
  • Previous diet-therapy attempts with at least a 5% weight loss in the last year
  • kg weight fluctuation in the last 3 months
  • Presumed or confirmed pregnancy
  • No contraceptive method for women in fertility age
  • Cardiopathies, nephropathies, hepatopathies, bronchopneumopathies, hemopathies dermopathies clinically significant chronic degenerative CNS (Central Nervous System) diseases
  • Active peptic ulcer, ulcerative colitis, Crohn disease, celiac disease, inflammatory bowel disease
  • Alcoholism
  • Epilepsy
  • Past or current malignancies
  • Intellectual disability
  • Significant motor disability
  • Drug abuse
  • Autoimmune diseases
  • Symptomatic cholelithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia

Pavia, Lombardy, 27100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 40898346DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mariangela Rondanelli, Prof.

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 5, 2020

Study Start

April 24, 2020

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

IT(1)