Trial | NCT03557424  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    165
The BEFORE study ((B) EFficacy Of REfigura) is designed to demonstrate the efficacy of REFIGURA®. It is a double-blind, randomized, monocentric study.
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:

placebo
Verum (in the normal, approved dose)
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 Started
Apr 26
2017
Primary Completion
Apr 16
2018
Study Completion
Apr 16
2018
Last Update
Jun 15
2018

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

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

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.

Polyglucosamine Glucomannan normal dose Experimental

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.

Polyglucosamine Glucomannan high dose Experimental

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.

Placebo Placebo Comparator

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.

Criteria 

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:

Overweight-related health disorder (e.g. Hypertension, type 2 Diabetes m.)
Abdominal Obesity
A disease aggravated by obesity
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.
No Results Posted