Efficacy of Polyglucosamine Long Term Treatment

NCT ID: NCT02682277

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-10-31

Brief 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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

polygucosamine

Intervention Type: DEVICE

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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

Interventions

polygucosamine

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

Intervention Type: DEVICE

placebo

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

Intervention Type: OTHER

Other Intervention Names

ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Certmedica International GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianni Belcaro

Role: PRINCIPAL_INVESTIGATOR

Irwine Labs University of Chieti

Umberto Cornelli, MD

Role: STUDY_DIRECTOR

Loyola University School of Medicine-Chicago

Locations

MAP Center

Rende, Cosenza, Italy

Countries

Italy

Other Identifiers

U111111292405

Identifier Type: OTHER

Identifier Source: secondary_id

003/14

Identifier Type: -

Identifier Source: org_study_id