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Efficacy of Polyglucosamine for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02410785
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Certmedica International GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Device: Polyglucosamine Other: Placebo Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation
Study Start Date : August 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Medical device polyglucosamine
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.
Device: Polyglucosamine
ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans

Placebo Comparator: Placebo
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.
Other: Placebo
Placebo tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410785


Locations
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Germany
Salztal Klinik GmbH
Bad Soden-Salmünster, Hessia, Germany, 63628
Italy
MAP Center
Rende, Cosenza, Italy, 87036
Sponsors and Collaborators
Certmedica International GmbH
Investigators
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Principal Investigator: Karina Pokhis, MD Salztal Klinik GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Certmedica International GmbH
ClinicalTrials.gov Identifier: NCT02410785    
Other Study ID Numbers: 001/09
U1111-1123-0658 ( Other Identifier: WHO )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Certmedica International GmbH:
obesity,
body weight,
overweight,
weight loss,
polyglucosamine,
L112
caloric restriction
physical activity
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes