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Completed

NCT Number: NCT02529631

RCT to Compare Orlistat and Polyglucosamine 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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetological Center, Dreieich, Hesse, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. BMI reduction

    Time frame: 12 weeks

    Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI

  2. Waist circumference reduction

    Time frame: 12 weeks

    Achieved change of the waist circumference of all participants in each group compared to the initial average WC

Sponsors and collaborators

Lead sponsor

Certmedica International GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Aug 20, 2015
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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