Overweight and ObesityPhase 4NCT03557424
BEFORE Study, Efficacy of Refigura
A Phase 4 study testing Polyglucosamine Glucomannan normal dose (Verum) and Polyglucosamine Glucomannan high dose (Verum) in people with Overweight and Obesity and Weight Loss, run by Heilpflanzenwohl AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Weight Loss, Efficacy, Self
- What is being tested?
- Polyglucosamine Glucomannan normal dose (Verum) and Polyglucosamine Glucomannan high dose (Verum)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2017to 16 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Weight Loss, Efficacy, Self
- Being tested
- Polyglucosamine Glucomannan normal dose (Verum), Polyglucosamine Glucomannan high dose (Verum), Placebo Comparator: Placebo
- Keywords
- Polyglucosamine, Glucomannan, Weight reduction, Weight loss, without change in lifestyle
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglucosamine Glucomannan normal dose (Verum)Drug
Also called Polyglucosamine Glucomannan normal dose
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)Drug
Also called Polyglucosamine Glucomannan high dose
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: PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Polyglucosamine Glucomannan normal dose (Verum) |
| 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. Receives: Drug: Polyglucosamine Glucomannan high dose (Verum) |
| 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. Receives: Drug: Placebo Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Secondary outcomes (3)
Changes in BMI
Changes in body-mass-index during the study. Comparison of the values obtained on day1 with results from day 65.
Measured: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Safety: occurence of adverse events
Explore the occurence of adverse Events in the three different arms.
Measured: Every week (from week 1 to week 10)
Changes in blood pressure
Changes in blood pressure values during the study. Comparison of the values obtained on day1 with results from day 65.
Measured: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start26 Apr 2017
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three armed, parallel, double blind, Placebo-controlled, interventional study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heilpflanzenwohl AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557424
- Sponsor's protocol ID
- BEFORE-Study
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEFORE-Study for the Evaluation of Safety and Efficacy of Polyglucosamin and Glucomannan Combination.
- ClinicalTrials.gov ID
- NCT03557424
- Acronym / sponsor ID
- BEFORE-Study
- Conditions
- Overweight and Obesity, Weight Loss, Efficacy, Self
- Keywords
- Polyglucosamine, Glucomannan, Weight reduction, Weight loss, without change in lifestyle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Heilpflanzenwohl AGIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Three armed, parallel, double blind, Placebo-controlled, interventional study
| Arm | Type | Receives |
|---|---|---|
| Polyglucosamine Glucomannan normal dose | Experimental | Drug: Polyglucosamine Glucomannan normal dose (Verum)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 | Drug: Polyglucosamine Glucomannan high dose (Verum)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 | Drug: Placebo Comparator: PlaceboPatients 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyglucosamine Glucomannan normal dose (Verum)Also: Polyglucosamine Glucomannan normal dosePatients 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. | Drug | Polyglucosamine Glucomannan normal dose |
| Polyglucosamine Glucomannan high dose (Verum)Also: Polyglucosamine Glucomannan high dosePatients 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. | Drug | Polyglucosamine Glucomannan high dose |
| Placebo Comparator: PlaceboPatients 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. | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Changes in BMI
Time frame: 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)
Changes in blood pressure
Time frame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyglucosamine Glucomannan normal dose (Verum) and Polyglucosamine Glucomannan high dose (Verum) in people with Overweight and Obesity and Weight Loss, run by Heilpflanzenwohl AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Bodyweight (time frame: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.