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BEFORE Study, Efficacy of Refigura

Primary Purpose

Overweight and Obesity, Weight Loss, Efficacy, Self

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Polyglucosamine Glucomannan normal dose (Verum)

Polyglucosamine Glucomannan high dose (Verum)

Placebo Comparator: Placebo

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Polyglucosamine, Glucomannan, Weight reduction, Weight loss, without change in lifestyle

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

MIT Gesundheit GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Polyglucosamine Glucomannan normal dose

Polyglucosamine Glucomannan high dose

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in BMI

Changes in body-mass-index during the study. Comparison of the values obtained on day1 with results from day 65.

Safety: occurence of adverse events

Explore the occurence of adverse Events in the three different arms.

Changes in blood pressure

Changes in blood pressure values during the study. Comparison of the values obtained on day1 with results from day 65.

Full Information

NCT ID

NCT03557424

First Posted

May 22, 2018

Last Updated

June 14, 2018

Sponsor

Heilpflanzenwohl AG

1. Study Identification

Unique Protocol Identification Number

NCT03557424

Brief Title

BEFORE Study, Efficacy of Refigura

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

April 26, 2017 (Actual)

Primary Completion Date

April 16, 2018 (Actual)

Study Completion Date

April 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Heilpflanzenwohl AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Weight Loss, Efficacy, Self

Keywords

Polyglucosamine, Glucomannan, Weight reduction, Weight loss, without change in lifestyle

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Three armed, parallel, double blind, Placebo-controlled, interventional study

Masking

ParticipantCare ProviderInvestigator

Masking Description

double-blind, randomized

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Polyglucosamine Glucomannan normal dose

Arm Type

Experimental

Arm Description

Arm Title

Polyglucosamine Glucomannan high dose

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Polyglucosamine Glucomannan normal dose (Verum)

Other Intervention Name(s)

Polyglucosamine Glucomannan normal dose

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Polyglucosamine Glucomannan high dose (Verum)

Other Intervention Name(s)

Polyglucosamine Glucomannan high dose

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator: Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in Bodyweight

Description

Changes in bodyweight during the study (weight reduction in kg). Comparison of the values obtained on day1 with results from day 65.

Time Frame

Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

Secondary Outcome Measure Information:

Title

Changes in BMI

Description

Changes in body-mass-index during the study. Comparison of the values obtained on day1 with results from day 65.

Time Frame

Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

Title

Safety: occurence of adverse events

Description

Explore the occurence of adverse Events in the three different arms.

Time Frame

Every week (from week 1 to week 10)

Title

Changes in blood pressure

Description

Changes in blood pressure values during the study. Comparison of the values obtained on day1 with results from day 65.

Time Frame

Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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: 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.

Facility Information:

Facility Name

MIT Gesundheit GmbH

City

Kleve

State/Province

NRW

ZIP/Postal Code

47533

Country

Germany

12. IPD Sharing Statement

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BEFORE Study, Efficacy of Refigura

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