Prospective, multicentric, randomised, double-blind, placebo-controlle trial in a parallel-group-design to demontrate weight reduction with polyglucosamine L112 in addition to the basic programme compared to placebo in patients with overweight or obesity
- Conditions
- overweight BMI 26 - 29.9E66.00
- Registration Number
- DRKS00003599
- Lead Sponsor
- Certmedica International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 322
Written consent after information;
overweight or ICD-10 E66.00;
Waist circumference female > 88 cm, male > 102 cm;
age 18 to 65 years; negative pregnancy testing and a correct/effective method of contraception;
physical activity and nutrition according to the clinical investigation plan must be possible;
presentation of ECG and blood sample results;
Age < 18, > 65 years respectively;
BMI < 26, > 34.9 respectively;
waist circumference female < 88 cm, male < 102 cm;
pregnant or nursing (lactating) women;
contraindication for a weight reduction:
malignant tumour; Diabetes Typ I and II;
actually increased fasting blood sugar;
chronicinflammatory bowel disease;
condition after intestinal operation;
heart insufficiency;
each other disease/treatment in the opinion of each investigator, which could interfear with the safety, compatibility or performance;
alcoholic, reliance on medication or drug addiction;
abuse of laxantia;
known allergy to crustaceans and other ingredients of the verum or placebo tablets;
longterm intake of medications that reduces intestinal movements;
intake of cortikosteroids;
not allowed comedication;
intake of vitamin K antagonists;
intake of medication which will cause interactions, or the are foreseeable and which can not be taken with a gap of four hours to the study medication;
weight reduction within the last 5 monts;
simultaneous participation in other clinical studies;
Inability to understand the sense and purpose of this clinical study or to comply with or fulfill the conditions of the clinical investigation plan
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of the patients with a weight-reduction of at least 5 per cent after 24 weeks, compared with base line
- Secondary Outcome Measures
Name Time Method Reduction of the body-fat compartment after 24 weeks compared to base line; <br>improvement of the pre-diabetes data after 24 weeks compared to base line.<br>Stabilisation of the body weight for a following 28 weeks compared to week 24; <br>reduction of the waist circumferenceof of at least 2 cm after 24 weeks compared to base line; <br>safety and compatibility during duration of the study of 52 weeks.<br>