BEFORE Study, Efficacy of Refigura
Overweight and Obesity, Weight Loss, Efficacy, Self
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
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.
Sites / Locations
- MIT Gesundheit GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Polyglucosamine Glucomannan normal dose
Polyglucosamine Glucomannan high dose
Placebo
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.