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

Phase 4

• Conditions: E66.00; E66.01

• Registration Number: DRKS00000358
• Lead Sponsor: Certmedica International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-08
• Study Completion: 2010-11-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight reduction of 5 to 10 per cent of the starting weight<br>weighted with calibrated balance in kilogramm <br>in week 0, 1 - 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 und 52<br>Reduction of the waist circumference of more than 4 cm.<br>measured in cm with a measuring tape<br>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 Outcome Measures

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