Polyglucosamine L112 in Overweight and Obese Subjects

August 20, 2021 updated by: Azienda di Servizi alla Persona di Pavia

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Azienda di Servizi alla Persona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control formula
Excipients and gum arabic in tablet
Combination product: Placebo
excipients and gum arabic
Active Comparator: Experimental formula
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes on anthropometric measures
Time Frame: Changes from baseline anthropometric measures at 90 days
Body weight (Kg)
Changes from baseline anthropometric measures at 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Changes from baseline lipid profile at 90 days
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
Changes from baseline insulin resistance at 90 days
Changes on Carbohydrate profile
Time Frame: Changes from baseline Carbohydrate profile at 90 days
Glycemia (mg/dl)
Changes from baseline Carbohydrate profile at 90 days
Changes on Carbohydrate profile
Time Frame: Changes from baseline Carbohydrate profile at 90 days
Insulin (mcU/ml)
Changes from baseline Carbohydrate profile at 90 days
Changes on safety
Time Frame: Changes from baseline safety at 90 days
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Changes from baseline safety at 90 days
Changes on safety
Time Frame: Changes from baseline safety at 90 days
Gamma glutamyl transferase (U/I)
Changes from baseline safety at 90 days
Changes on safety
Time Frame: Changes from baseline safety at 90 days
Creatinine (mg/dl)
Changes from baseline safety at 90 days
Changes on anthropometric measures
Time Frame: Changes from baseline anthropometric measures at 90 days
Waist circumference (cm)
Changes from baseline anthropometric measures at 90 days
Changes on anthropometric measures
Time Frame: Changes from baseline anthropometric measures at 90 days
Body Mass Index (Kg/m2)
Changes from baseline anthropometric measures at 90 days
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)
Changes from baseline body composition at 90 days
Changes on oxidative stress
Time Frame: Changes from baseline oxidative stress at 90 days
Reactive Oxygen Species (CARR U)
Changes from baseline oxidative stress at 90 days
Changes on oxidative stress
Time Frame: Changes from baseline oxidative stress at 90 days
Total Antioxidant Capacity (ORAC U)
Changes from baseline oxidative stress at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda di Servizi alla Persona di Pavia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mariangela Rondanelli, Fondazione Casemiro Mondino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200037586

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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