Back to resultsRCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
orlistat 60 mg
polyglucosamine
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Polyglucosamine, L 112, overweight,, obesity, orlistat, weight reduction
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
Sites / Locations
- Diabetological Center
- MAP Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Drug: orlistat 60mg capsules
Medical device: polyglucosamine
Arm 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
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
Outcomes
Primary Outcome Measures
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
Secondary Outcome Measures
BMI reduction
Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI
Waist circumference reduction
Achieved change of the waist circumference of all participants in each group compared to the initial average WC
Full Information
NCT ID
NCT02529631
First Posted
July 24, 2015
Last Updated
August 19, 2015
Sponsor
Certmedica International GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02529631
Brief Title
RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Certmedica International GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Polyglucosamine, L 112, overweight,, obesity, orlistat, weight reduction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: orlistat 60mg capsules
Arm Type
Active Comparator
Arm 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
Arm Title
Medical device: polyglucosamine
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
orlistat 60 mg
Intervention Description
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
Device
Intervention Name(s)
polyglucosamine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
BMI reduction
Description
Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI
Time Frame
12 weeks
Title
Waist circumference reduction
Description
Achieved change of the waist circumference of all participants in each group compared to the initial average WC
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Stoll, MD
Organizational Affiliation
Diabetological centre, Dreieich, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Umberto Cornelli, MD
Organizational Affiliation
CorCon, Mailand, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetological Center
City
Dreieich
State/Province
Hesse
ZIP/Postal Code
63303
Country
Germany
Facility Name
MAP Center
City
Rende
State/Province
Cosenza
ZIP/Postal Code
87036
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
28097013
Citation
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.
Results Reference
derived
Learn more about this trial
RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity
We'll reach out to this number within 24 hrs