RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity

Certmedica

Status: Completed

Conditions: Overweight; Obesity

Treatments: Device: polyglucosamine; Drug: orlistat 60 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02529631

003/07

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Drug: orlistat 60mg capsules

Active Comparator group

Description:

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

Treatment:

Drug: orlistat 60 mg

Medical device: polyglucosamine

Active Comparator group

Description:

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

Treatment:

Device: polyglucosamine