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Efficacy of Polyglucosamine for Weight Loss

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02410785
Enrollment
115
Registered
2015-04-08
Start date
2009-08-31
Completion date
2010-10-31
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

obesity,, body weight,, overweight,, weight loss,, polyglucosamine,, L112, caloric restriction, physical activity

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.

Interventions

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

OTHERPlacebo

Placebo tablet

Sponsors

Certmedica International GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.24 weeks

Secondary

MeasureTime frame
Change of body weight in kg24 weeks
Change of BMI24 weeks
Reduction of waist circumference24 weeks

Countries

Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026