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

NCT ID: NCT02529631

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-08-31

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Drug: orlistat 60mg capsules

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

Group Type: ACTIVE_COMPARATOR

orlistat 60 mg

Intervention Type: DRUG

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.

Medical device: polyglucosamine

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

Group Type: ACTIVE_COMPARATOR

polyglucosamine

Intervention Type: DEVICE

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).

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Certmedica International GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manfred Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetological centre, Dreieich, Germany

Umberto Cornelli, MD

Role: PRINCIPAL_INVESTIGATOR

CorCon, Mailand, Italy

Locations

Diabetological Center

Dreieich, Hesse, Germany

MAP Center

Rende, Cosenza, Italy

Countries

Germany; Italy

References

Stoll M, Bitterlich N, Cornelli U. Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity. BMC Obes. 2017 Jan 11;4:4. doi: 10.1186/s40608-016-0130-4. eCollection 2017.

Reference Type: DERIVED

PMID: 28097013 (View on PubMed)

Other Identifiers

003/07

Identifier Type: -

Identifier Source: org_study_id