overweight BMI 26 - 29.9 E66.00
Conditions
Interventions
Group 1: For 24 weeks a Hypocaloric diet (500 kcal) according to the guidance paper of the concerned peer associations, plus polyglucosamine L112 (formoline L112) tablets
2 x 2 tablets taken together with the two main meals.
Beginning with week 25: 2 x 1 tablet taken together with the two main mails
Group 2: For 24 weeks a Hypocaloric diet (500 kcal) according to the g
2 x 2 tablets taken together with two main meals.
Beginning with week 25: 2 x 1 tablet taken together with the two main meals
Sponsors
Certmedica International GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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;
Exclusion criteria
Exclusion criteria: Age 65 years respectively; BMI 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of the patients with a weight-reduction of at least 5 per cent after 24 weeks, compared with base line | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of the body-fat compartment after 24 weeks compared to base line; improvement of the pre-diabetes data after 24 weeks compared to base line. Stabilisation of the body weight for a following 28 weeks compared to week 24; reduction of the waist circumferenceof of at least 2 cm after 24 weeks compared to base line; safety and compatibility during duration of the study of 52 weeks. | — |
Countries
Germany
Contacts
Public ContactAnnette Chen-Stute
Adipositas Zentrum Oberhausen
Outcome results
None listed