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OpenTrials
Completed

NCT Number: NCT02410785

Efficacy of Polyglucosamine for Weight Loss

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salztal Klinik GmbH, Bad Soden-Salmünster, Hessia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyglucosamine

Device

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

Placebo

Other

Placebo tablet

Primary outcomes

  1. Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.

    Time frame: 24 weeks

Secondary outcomes

  1. Change of body weight in kg

    Time frame: 24 weeks

  2. Change of BMI

    Time frame: 24 weeks

  3. Reduction of waist circumference

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Certmedica International GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 8, 2015
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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