Efficacy of Polyglucosamine for Weight Loss
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Polyglucosamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring obesity,, body weight,, overweight,, weight loss,, polyglucosamine,, L112, caloric restriction, physical activity
Eligibility 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
Sites / Locations
- Salztal Klinik GmbH
- MAP Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Medical device polyglucosamine
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.
Secondary Outcome Measures
Change of body weight in kg
Change of BMI
Reduction of waist circumference
Full Information
NCT ID
NCT02410785
First Posted
March 27, 2015
Last Updated
January 26, 2016
Sponsor
Certmedica International GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02410785
Brief Title
Efficacy of Polyglucosamine for Weight Loss
Official Title
Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Certmedica International GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
obesity,, body weight,, overweight,, weight loss,, polyglucosamine,, L112, caloric restriction, physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical device polyglucosamine
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Polyglucosamine
Intervention Description
ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change of body weight in kg
Time Frame
24 weeks
Title
Change of BMI
Time Frame
24 weeks
Title
Reduction of waist circumference
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karina Pokhis, MD
Organizational Affiliation
Salztal Klinik GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salztal Klinik GmbH
City
Bad Soden-Salmünster
State/Province
Hessia
ZIP/Postal Code
63628
Country
Germany
Facility Name
MAP Center
City
Rende
State/Province
Cosenza
ZIP/Postal Code
87036
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26217540
Citation
Pokhis K, Bitterlich N, Cornelli U, Cassano G. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation. BMC Obes. 2015 Jun 10;2:25. doi: 10.1186/s40608-015-0053-5. eCollection 2015.
Results Reference
derived
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Efficacy of Polyglucosamine for Weight Loss
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