BEFORE Study, Efficacy of Refigura
Condition: Overweight and Obesity; Weight Loss; Efficacy, Self
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The BEFORE study ((B) EFficacy Of REfigura) is designed to demonstrate the efficacy of
      REFIGURA®. It is a double-blind, randomized, monocentric study.
    

Detailed description: 
      Core data from the BEFORE study:

      Sponsor: Heilpflanzenwohl AG Product: REFIGURA® Title: BEFORE study: Demonstrating the
      efficacy of REFIGURA® through a double-blind, three-arm, randomized, monocentric study Study
      duration: 8 weeks (56 days) Study location: MIT Gesundheit GmbH, Stechbahn 20-22, 47533 Kleve
      CRO: MIT Health GmbH, Stechbahn 20-22, 47533 Kleve Number of study participants: 165 (55
      patients per treatment arm)

      Summary:

      REFIGURA® (manufactured by KITOZYME, Parc Industriel des Hauts-Sarts, Zone 2, Rue de Milmort,
      680, BE-4040 Herstal, Belgium, Distribution: Heilpflanzenwohlkraft GmbH), is an approved
      medical device containing a combination of chitosan (a polyglucosamine ) and glucomannan.
      Chitosan is a vegetable fiber that binds fats in the intestinal lumen. Both substances are
      already approved and show few side effects. They are not absorbed into the body, but work
      directly in the intestine.

      The investigational medicinal products are used to treat obesity (weight loss) and to control
      weight. The effect is based on a reduction in caloric intake, by increasing the feeling of
      satiety and at the same time the appetite is reduced. As a result, the amount of food
      consumed is reduced and excessive food (cravings attacks) is prevented. It also reduces the
      intake of dietary fats.

      The study compares three treatment arms:

        1. placebo

        2. Verum (in the normal, approved dose)

        3. Verum (in the double dose)

      The patients are weighed, their body fat content is measured and the body size is measured.
      All measurement methods are non-invasive.
    

Intervention name(s): Polyglucosamine Glucomannan normal dose (Verum); Polyglucosamine Glucomannan high dose (Verum); Placebo Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received Verum three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.; Patients received Verum 2 three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.; Patients received Placebo three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.
Other intervention name(s): Polyglucosamine Glucomannan normal dose; Polyglucosamine Glucomannan high dose
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three armed, parallel, double blind, Placebo-controlled, interventional study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Polyglucosamine; Glucomannan; Weight reduction; Weight loss; without change in lifestyle