Efficacy of Polyglucosamine for Weight Loss

Overweight and 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: NCT02410785
• Other study ID #: 001/09
• Secondary ID: U1111-1123-0658
• Status: Completed
• Phase: N/A
• First received: March 27, 2015
• Last updated: January 26, 2016
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: March 2015
• Source: Certmedica International GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The polyglucosamine, specification L112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.

Description:

To have a comparable diet condition, all participants in both groups had to follow the recommendations of the German clinical practice guidelines on the management and prevention of obesity.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. 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 in 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: 115
• Est. completion date: October 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• BMI > 26 and < 45

• 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 and known hypersensitivity reactions to crustaceans

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Device:
• Polyglucosamine
ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans

Other:
• Placebo
Placebo tablet

Locations

Country	Name	City	State
Germany	Salztal Klinik GmbH	Bad Soden-Salmünster	Hessia
Italy	MAP Center	Rende	Cosenza

Sponsors (1)

Lead Sponsor	Collaborator
Certmedica International GmbH

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.		24 weeks	Yes
Secondary	Change of body weight in kg		24 weeks	Yes
Secondary	Change of BMI		24 weeks	Yes
Secondary	Reduction of waist circumference		24 weeks	Yes