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OpenTrials
Completed

NCT Number: NCT02682277

Efficacy of Polyglucosamine Long Term Treatment

The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.

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Key information

Conditions

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

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MAP Center

Rende, Cosenza, 87036, Italy

About this study

Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI >30 and < 35
  • waist circumference of more than 88 cm for women and greater than 102 for men

Exclusion criteria

  • pregnancy or breast-feeding
  • alcohol abuse
  • drug abuse or drug addiction
  • inability to fulfill the criteria of the trial protocol
  • cancer diseases
  • malignant tumors
  • pre-existence of chronic intestinal disease
  • known hypersensitivity reactions to crustaceans

Treatment and study plan

polygucosamine

Device

2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

Other names: ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine

Placebo

Other

2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

Primary outcomes

  1. Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.

    Time frame: 12 months

Secondary outcomes

  1. Change of body weight in kg

    Time frame: 12 months

  2. Change of BMI

    Time frame: 12 monts

  3. Reduction of waist circumference

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Certmedica International GmbH

Industry

Registry information

Official study title

Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2016
Registry last updated
Jul 25, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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