NCT05022732

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 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

May 5, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 20, 2021

Last Update Submit

August 20, 2021

Conditions

Obesity

Keywords

ObesityPolyglucosamineBody compositionInflammation

Outcome Measures

Primary Outcomes (1)

  • Changes on anthropometric measures

    Body weight (Kg)

    Changes from baseline anthropometric measures at 90 days

Secondary Outcomes (12)

  • Changes on lipid profile

    Changes from baseline lipid profile at 90 days

  • Changes on insulin resistance

    Changes from baseline insulin resistance at 90 days

  • Changes on Carbohydrate profile

    Changes from baseline Carbohydrate profile at 90 days

  • Changes on Carbohydrate profile

    Changes from baseline Carbohydrate profile at 90 days

  • Changes on safety

    Changes from baseline safety at 90 days

  • +7 more secondary outcomes

Study Arms (2)

Control formula

PLACEBO COMPARATOR

Excipients and gum arabic in tablet

Combination Product: Placebo

Experimental formula

ACTIVE COMPARATOR

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

Interventions

Polyglucosamine L112DIETARY_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

Experimental formula
PlaceboCOMBINATION_PRODUCT

excipients and gum arabic

Control formula

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

ObesityInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Mariangela Rondanelli

    Fondazione Casemiro Mondino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2021

First Posted

August 26, 2021

Study Start

May 5, 2020

Primary Completion

August 5, 2020

Study Completion

August 19, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

IT(1)