BEFORE Study, Efficacy of Refigura

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557424
• Other study ID #: BEFORE-Study
• Status: Completed
• Phase: Phase 4
• Start date: April 26, 2017
• Est. completion date: April 16, 2018

Study information

• Verified date: June 2018
• Source: Heilpflanzenwohl AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy, Self
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	MIT Gesundheit GmbH	Kleve	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heilpflanzenwohl AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Bodyweight	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	Changes in BMI	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)
Secondary	Safety: occurence of adverse events	Explore the occurence of adverse Events in the three different arms.	Every week (from week 1 to week 10)
Secondary	Changes in blood pressure	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)