Efficacy of Polyglucosamine Long Term Treatment

July 21, 2017 updated by: Certmedica International GmbH

Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation

The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • 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
    • Cosenza
      • Rende, Cosenza, Italy, 87036
        • MAP Center

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

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI >30 and < 35
  • waist circumference of more than 88 cm for women and greater than 102 for men

Exclusion Criteria:

  • pregnancy or breast-feeding
  • alcohol abuse
  • drug abuse or drug addiction
  • inability to fulfill the criteria of the trial protocol
  • cancer diseases
  • malignant tumors
  • pre-existence of chronic intestinal disease
  • known hypersensitivity reactions to crustaceans

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medical device polyglucosamine
2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity
Device: polygucosamine
2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
Other Names:
  • ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine
Placebo Comparator: Placebo
2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity
Other: placebo
2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of body weight in kg
Time Frame: 12 months
12 months
Change of BMI
Time Frame: 12 monts
12 monts
Reduction of waist circumference
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Certmedica International GmbH

Investigators

  • Principal Investigator: Gianni Belcaro, Irwine Labs University of Chieti
  • Study Director: Umberto Cornelli, MD, Loyola University School of Medicine-Chicago

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)

May 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003/14
  • U111111292405 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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