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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529631
• Other study ID #: 003/07
• Status: Completed
• Phase: N/A
• First received: July 24, 2015
• Last updated: August 19, 2015
• Start date: November 2009
• Est. completion date: August 2013

Study information

• Verified date: August 2015
• Source: Certmedica International GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2013
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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).

Locations

Country	Name	City	State
Germany	Diabetological Center	Dreieich	Hesse
Italy	MAP Center	Rende	Cosenza

Sponsors (1)

Lead Sponsor	Collaborator
Certmedica International GmbH

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.		12 weeks	Yes
Secondary	BMI reduction	Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI	12 weeks	Yes
Secondary	Waist circumference reduction	Achieved change of the waist circumference of all participants in each group compared to the initial average WC	12 weeks	Yes