BEFORE Study, Efficacy of Refigura

June 14, 2018 updated by: Heilpflanzenwohl AG

BEFORE-Study for the Evaluation of Safety and Efficacy of Polyglucosamin and Glucomannan Combination.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Kleve, NRW, Germany, 47533
        • MIT Gesundheit GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-50 years
  • Body mass index (BMI) ≥ 30 kg/m² or

  • BMI between 25 and ˂ 30 kg/m² and simultaneous existence of at least one of the following factors:

    1. Overweight-related health disorder (e.g. Hypertension, type 2 Diabetes m.)
    2. Abdominal Obesity
    3. A disease aggravated by obesity
    4. High psychosocial pressure of suffering

Exclusion Criteria:

  • Pregnancy (examination with the help of a pregnancy test using urine Lab Test at V2) and lactation
  • Alcohol, drugs and drug abuse
  • Limited compliance (pre-questionnaire examination)
  • History of malignant tumors
  • (chronic) Inflammatory diseases of the gastrointestinal tract
  • Gastroparesis (stomach paralysis) in the anamnesis
  • Signs of an intestinal closure (arising or existing mechanical or paralytic Ileus) in the anamnesis
  • Gastric bridging surgery or gastric reduction
  • Hypersensitivity or allergy to the ingredients
  • Untreated or inadequately treated hypertension
  • Diabetes mellitus (examination with the help of a urine tests)
  • Treatment with diuretics or insulin
  • Cortisone, which has a systemic effect
  • Smokers who want to start weaning during the trial
  • Untreated or insufficiently treated thyriodale disorders (if the patient is stable in the opinion of the physician, he may participate in the study)
  • Cardiac edema
  • Participation in weight reduction programs in the past 30 days
  • Patients with swallowing problems, intestinal polyps or severe digestive disorders
  • Patients with a history of constipation
  • Patients who take drugs containing fat-soluble active substances and in which the time-consuming conditions of these drugs (see instructions for taking in Appendix O) are incompatible with the intake instructions of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyglucosamine Glucomannan normal dose
Patients received the single dose Polyglucosamine und Glucomannan (0,5 g resp. 1 g per Stick) three times per day over 65 days. The drug is administered as a powder which is dissolved in water. The solution is taken orally.
Drug: Polyglucosamine Glucomannan normal dose (Verum)
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.
Other Names:
  • Polyglucosamine Glucomannan normal dose
Experimental: Polyglucosamine Glucomannan high dose
Patients received the higher dose of Polyglucosamine und Glucomannan (1 g resp. 1,34 g per Stick) three times per day over 65 days. The drug is administered as a powder which is dissolved in water. The solution is taken orally.
Drug: Polyglucosamine Glucomannan high dose (Verum)
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.
Other Names:
  • Polyglucosamine Glucomannan high dose
Placebo Comparator: Placebo
Patients received Placebo three times per day over 65 days. The Placebo is administered according to the respective Intervention (Drug: Placebo Comparator: Placebo) as a powder which is dissolved in water. The solution is taken orally.
Drug: Placebo Comparator: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Bodyweight
Time Frame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Changes in bodyweight during the study (weight reduction in kg). Comparison of the values obtained on day1 with results from day 65.
Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in BMI
Time Frame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Changes in body-mass-index during the study. Comparison of the values obtained on day1 with results from day 65.
Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Safety: occurence of adverse events
Time Frame: Every week (from week 1 to week 10)
Explore the occurence of adverse Events in the three different arms.
Every week (from week 1 to week 10)
Changes in blood pressure
Time Frame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Changes in blood pressure values during the study. Comparison of the values obtained on day1 with results from day 65.
Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heilpflanzenwohl AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Actual)

April 16, 2018

Study Completion (Actual)

April 16, 2018

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEFORE-Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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