Efficacy of Polyglucosamine Long Term Treatment

Certmedica

Status: Completed

Conditions: Obesity

Treatments: Other: placebo; Device: polygucosamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02682277

003/14

U111111292405 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Medical device polyglucosamine

Active Comparator group

Description:

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

Treatment:

Device: polygucosamine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo