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

NCT02529631 | Completed

• 1 other identifier: 003/07
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 2

Brief Summary

This trial compares two treatment methods:

1. 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. 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

Keywords

Polyglucosamine; L 112; overweight,; obesity; orlistat; weight reduction

Outcome Measures

Primary Outcomes (1)

• Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.

  12 weeks

Secondary Outcomes (2)

• BMI reduction

  12 weeks

• Waist circumference reduction

  12 weeks

Study Arms (2)

Drug: orlistat 60mg capsules

ACTIVE COMPARATOR

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

Medical device: polyglucosamine

ACTIVE COMPARATOR

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

Interventions

orlistat 60 mg 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.

Drug: orlistat 60mg capsules

polyglucosamine 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).

Medical device: polyglucosamine

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 28 kg/m² and \< 45 kg/m²
• Waist circumference \> 80 cm (women) \> 94 cm (men)

You may not qualify if:

• 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

Sponsors & Collaborators

• Certmedica International GmbH: lead

Study Sites (2)

Diabetological Center

Dreieich, Hesse, 63303, Germany

Location

MAP Center

Rende, Cosenza, 87036, Italy

Location

Related Publications (1)

• 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.

  PMID: 28097013 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

Orlistat

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals

Study Officials

• Manfred Stoll, MD

  Diabetological centre, Dreieich, Germany

  PRINCIPAL INVESTIGATOR

• Umberto Cornelli, MD

  CorCon, Mailand, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: August 20, 2015
• Study Start: November 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2013
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

IT (1); DE (1)