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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: orlistat 60 mg; Device: polyglucosamine

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Dreieich, Hesse, Germany, 63303
      • Diabetological Center
• Italy
  • Cosenza
    • Rende, Cosenza, Italy, 87036
      • MAP Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.
Active Comparator: 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	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).

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI reduction	Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI	12 weeks
Waist circumference reduction	Achieved change of the waist circumference of all participants in each group compared to the initial average WC	12 weeks

Collaborators and Investigators

• Sponsor: Certmedica International GmbH
• Investigators: Principal Investigator: Manfred Stoll, MD, Diabetological centre, Dreieich, Germany; Principal Investigator: Umberto Cornelli, MD, CorCon, Mailand, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 24, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: obesity; orlistat; weight reduction; Polyglucosamine; overweight,; L 112
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: 003/07