Efficacy of Polyglucosamine Long Term Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02682277

Enrollment

100

Registered

2016-02-15

Start date

2014-05-31

Completion date

2016-10-31

Last updated

2017-07-25

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

Conditions

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 in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.

Detailed description

Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested. One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. 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 is 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

DEVICEpolygucosamine

2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

OTHERplacebo

2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI \>30 and \< 35 * 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 * known hypersensitivity reactions to crustaceans

Design outcomes

Primary

Measure	Time frame
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.	12 months

Secondary

Measure	Time frame
Change of body weight in kg	12 months
Change of BMI	12 monts
Reduction of waist circumference	12 months

Countries

Italy

Outcome results

None listed

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