Trial | NCT02529631  Report issue

Title

RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity
Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    64
This trial compares two treatment methods:

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.
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.
Study Started
Nov 30
2009
Primary Completion
Jun 30
2010
Study Completion
Aug 31
2013
Last Update
Aug 20
2015
Estimate

Drug orlistat 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.

Device polyglucosamine

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).

Drug: orlistat 60mg capsules Active Comparator

A tailored blister-strip for one day contains three capsules with orlistat 60mg Administration: 3 times daily 1 capsule with each meal containing fat concomitant with six placebo tablets Administration: 3 times daily 2 tablets with each main meal

Medical device: polyglucosamine Active Comparator

A tailored blister-strip for one day contains three placebo capsules Administration: 3 times daily 1 capsule with each meal containing fat concomitant with six tablets Administration: 3 times daily 2 tablets (whereas the 2 tablets in the mold "breakfast" are placebo tablets and the remaining 4 tablets for lunch and dinner contains poliglucosamine

Criteria 

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
No Results Posted