Obesity, Overweight
Conditions
Keywords
Polyglucosamine, L 112, overweight,, obesity, orlistat, weight reduction
Brief summary
This trial compares two treatment methods: 1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. Important is also that it is taken along with a reduced-calorie and low-fat diet. 2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.
Interventions
DRUGorlistat 60 mg
In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity. Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three orlistat 60 g capsules plus six placebo tablets.
DEVICEpolyglucosamine
In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity. Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three blue placebo capsules plus two placebo tablets (morning) and four polyglucosamine tablets (noon and evening).
Sponsors
Certmedica International GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI ≥ 28 kg/m² and \< 45 kg/m² * Waist circumference \> 80 cm (women) \> 94 cm (men)
Exclusion criteria
* Energy intake lower than the standard value according to Miffin St-Jeor equation * Pregnancy or breast-feeding * Addiction to alcohol * Inability to fulfil the requirement of the trial protocol * Cancer ,malignant tumour * Hypersensitivity reactions to crustaceans or ingredient of the study medication * Chronic diseases not under control with adequate therapy * Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight. | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI reduction | 12 weeks | Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI |
| Waist circumference reduction | 12 weeks | Achieved change of the waist circumference of all participants in each group compared to the initial average WC |
Countries
Germany, Italy
Outcome results
None listed