The product alli and the comparsion product fromoline L112 (medical device) decrease weight by influencing the fat absorption. The effects of both regimes should cause similar results in weight loss.
Conditions
Interventions
Trade Name: alli, trademark of GlaxoSmithKline
Product Name: alli - orlistat 60 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: Orlistat 60 mg
CAS Number: not applicab
Pharmaceutical form of the
Sponsors
Certmedica International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: overwieghte with BMI >28 diabetes mellitus type 2 body circumference > 80 cm in women or > 94 cm in men age between 21 or 60 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: gravidity or breastfeeding addiction of alcohol, medicaments or drugs impossibility to fulfill the criteria of the trial protocol carcinoma, malignoma known allergy against crstacea or another ingredient existing chronic instestinal deseases or obstipation under medical treatment state after intestinal surgery treatment with steroid hormones with a dose regimen more than 1 time per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: weight loss of 3-5 % compared to baseline weight decrease of the body cicumference more than 2 cm;Secondary Objective: Change in bloodparameters (Cholesterol, LDL, HDL, TG, Pro-insuline, Adiponectine) Blood pressure measurement of bio impedance anti oxidative capacity;Primary end point(s): weight reduction in an observational time of 12 weeks | — |
Countries
Germany
Outcome results
None listed