Efficacy of Polyglucosamine Long Term Treatment

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682277
• Other study ID #: 003/14
• Secondary ID: U111111292405
• Status: Completed
• Phase: N/A
• First received: February 10, 2016
• Last updated: July 21, 2017
• Start date: May 2014
• Est. completion date: October 31, 2016

Study information

• Verified date: February 2017
• Source: Certmedica International GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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:
• placebo
2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

Locations

Country	Name	City	State
Italy	MAP Center	Rende	Cosenza

Sponsors (1)

Lead Sponsor	Collaborator
Certmedica International GmbH

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.		12 months
Secondary	Change of body weight in kg		12 months
Secondary	Change of BMI		12 monts
Secondary	Reduction of waist circumference		12 months