Multicentric, randomised, double-blind, placebo-controlled 12-months-study in overweight or obese patients to compare two treatment regimes (polyglucosamine L112 vs. placebo)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000358

Enrollment

100

Registered

2010-03-08

Start date

2009-08-03

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E66.00 E66.01

Interventions

Group 1: Week 1 to 40 2 x 2 tablets per day with polyglucosamine L112 with the two main meals with the highest fat content Week 41 to 52 2 x 1 tablet per day with polyglucosamine L112 with the two mai

Eligibility

Sex/Gender

All

Age

21 Years to 65 Years

Inclusion criteria

Inclusion criteria: Overweight with BMI > 30 up to 39,9 Women: waist circumference > 88 cm Men: waist circumference > 102 cm

Exclusion criteria

Exclusion criteria: Pregnancy or breast-feeding Accohol- medication- or drugdependency Unability to fulfil the criteria of the trial protocol Malignoma Known hypersensivity against crustaceans Existing chronic, intestinal diseases, like a required treatment because of an constipation After intestinal surgery Metabolic disorders Ongoing required medication (to reduce the motility like opiates)

Design outcomes

Primary

Measure	Time frame
Weight reduction of 5 to 10 per cent of the starting weight weighted with calibrated balance in kilogramm in week 0, 1 - 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 und 52 Reduction of the waist circumference of more than 4 cm. measured in cm with a measuring tape Stabilising of the reduced weight in the observation period between week 40 and week 52 with a maximum weight increase of up to 1 per cent of the starting weight (in week 40) for both treatment groups	—

Measure

Time frame

Weight reduction of 5 to 10 per cent of the starting weight weighted with calibrated balance in kilogramm in week 0, 1 - 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 und 52 Reduction of the waist circumference of more than 4 cm. measured in cm with a measuring tape Stabilising of the reduced weight in the observation period between week 40 and week 52 with a maximum weight increase of up to 1 per cent of the starting weight (in week 40) for both treatment groups

—

Secondary

Measure	Time frame
Bio-impedanceanalysis (BIA) meassurement non-invasive, utilise the different electrical conductivity of bones, organs, muscles and body fat in per cent (%). (% fat content, % fat mass, % lean mass (fat free mass)) at week 0,12, 28, 40 and 52. Blood pressure measurement: non-invasive blood pressure (NIBP) in week 0, 1 to 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 an 52. Improvement of blood lipid levels; blood samples are taken to a laboratory for - Vitamin D (25 hydroxyvitamin D) in plasma at week 0, 12, 40 and 52. (with reduced Vitamin D levels in plasma at the examinations, vitamin D must be substituted (i.e. LIPOaktiv vital with 5 microgramm per day) - CRP sensitiv at week 0, 12, 40 and 52 - Adiponectin at week 0, 40 and 52	—

Measure

Time frame

Bio-impedanceanalysis (BIA) meassurement non-invasive, utilise the different electrical conductivity of bones, organs, muscles and body fat in per cent (%). (% fat content, % fat mass, % lean mass (fat free mass)) at week 0,12, 28, 40 and 52. Blood pressure measurement: non-invasive blood pressure (NIBP) in week 0, 1 to 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 an 52. Improvement of blood lipid levels; blood samples are taken to a laboratory for - Vitamin D (25 hydroxyvitamin D) in plasma at week 0, 12, 40 and 52. (with reduced Vitamin D levels in plasma at the examinations, vitamin D must be substituted (i.e. LIPOaktiv vital with 5 microgramm per day) - CRP sensitiv at week 0, 12, 40 and 52 - Adiponectin at week 0, 40 and 52

—

Countries

Austria, Germany

Contacts

Public ContactKarmen;Karina Elcic-Mihaljevic;Pokhis

Ordination;Salztal Klinik GmbH & Co. KG

dr-kem@chello.at;salztalklinik@t-online.de+4319420989;+49 6056 745 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026