Efficacy of Polyglucosamine for Weight Loss

Certmedica

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: Placebo; Device: Polyglucosamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02410785

U1111-1123-0658 (Other Identifier)

001/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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115 participants in 2 patient groups, including a placebo group

Medical device polyglucosamine

Active Comparator group

Description:

2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.

Treatment:

Device: Polyglucosamine

Placebo

Placebo Comparator group

Description:

2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.

Treatment:

Other: Placebo