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

INTERVENTION: Intervention 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 main meals with the highest fat content Intervention 2: week 1 to 40 2x 2 tablets per day with placebo with the two main meals with the highest fat content week 41 to 52 2 x 1 tablet per day with placebo with the two main meals with the highest fat content CONDITION: E66.00 ‐ [generalization E66.0: Obesity due to excess calories] E66.01 ‐ [generalization E66.0: Obesity due to excess calories] PRIMARY OUTCOME: 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 OUTCOME: 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 INCLUSION CRITERIA: Overweight with BMI > 30 up to 39,9 Women: waist circumference > 88 cm Men: waist circumference > 102 cm