Clinical trial NCT03557424: BEFORE Study, Efficacy of Refigura
Official title: BEFORE-Study for the Evaluation of Safety and Efficacy of Polyglucosamin and Glucomannan Combination.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight and Obesity
Weight Loss
Efficacy, Self
Keywords: Polyglucosamine
Glucomannan
Weight reduction
Weight loss
without change in lifestyle
Lead sponsor: Heilpflanzenwohl AG
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three armed, parallel, double blind, Placebo-controlled, interventional study
Primary purpose: TREATMENT

Brief 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.

Eligibility 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:

  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.

Primary outcomes:
measure: Changes in Bodyweight
timeFrame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Secondary outcomes:
measure: Changes in BMI
timeFrame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
measure: Safety: occurence of adverse events
timeFrame: Every week (from week 1 to week 10)
measure: Changes in blood pressure
timeFrame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Other outcomes:
Locations:
city: Kleve
country: Germany
facility: MIT Gesundheit GmbH
state: NRW
Study officials:
References: