Status:
COMPLETED
Policaptil Gel Retard® in Overweight and Mild Obese Subjects
Lead Sponsor:
Aboca Spa Societa' Agricola
Collaborating Sponsors:
Sprim Advanced Life Sciences
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This is a randomized, double blind, placebo controlled, interventional clinical study aimed at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the glycemic, lipid and...
Detailed Description
This is a randomized, double blind, placebo controlled, interventional clinical study on a medical device Visit schedule V1 (day -25) - Screening Visit During this visit (V1) the Investigator will col...
Eligibility Criteria
Inclusion
- Male and female subjects 18 - 60 years old (18 and 60 included).
- BMI ≥ 25 Kg/m2 and ≤ 34.9 Kg/m2.
- Stable body weight for the 3 months before enrollment.
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- Subjects who agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state (according to the forbidden food ingredients or supplements, that have to be avoided, as outlined in the study protocol), apart from the Treatment Period, during which they agree to follow the assigned diet.
- Subjects who agree not to make any major lifestyle changes (e.g. changing their exercise pattern, except as for what specified in the protocol for the Treatment Period) during the trial.
- Consent to the study and willing to comply with all its procedures.
- Postmenopausal women i.e. women who have not experienced a menstrual bleed for a minimum of 12 months or women who have undergone surgical sterilization (tubal closure or ovaries removal). Otherwise, necessity for women of childbearing potential to follow a reliable contraceptive treatment.Contraceptive treatments deemed as reliable for the study purposes are the following: hormonal contraceptives (pill, patch, vaginal ring), intrauterine devices (IUD), subcutaneous implants; barrier systems as condoms or diaphragm and methods based on the recognition of fertility from an hormonal point of view.
Exclusion
- Gastrointestinal disorders (i.e. gastric ulcer, Inflammatory Bowel Disease (IBD) / Irritable Bowel Syndrome (IBS)),
- Uncontrolled hypertension (defined as systolic blood pressure ≥180mmHg and / or diastolic blood pressure ≥100mmHg),
- Diabetes as defined by international criteria.
- Chronic liver disease with increased serum transaminase levels (SGOT and / or SGPT \> 2 UNL).
- Thyroid disorders (i.e. hyperthyroidism or hypothyroidism).
- Impaired renal function defined as estimated glomerular filtration rate (e-GFR) \<60mL/min/1.73m2 according to Modification of Diet in renal Disease (MDRD) formula due to kidney failure or kidney disease / disorders.
- Blood disorders (i.e. anemia) or subjects who donated their blood within 1 month prior to enrolment or had an important blood loss.
- Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety, compliance with the protocol and/or ability to complete the study.
- Previous gastrointestinal surgery except for appendectomy, hernia surgery, polypectomy, biopsies, colonic and gastric endoscopy.
- History of alcohol, drug or medication abuse.
- Known hypersensitivity or intolerance to the ingredients contained in the test product or the placebo; celiac subjects.
- Female subjects breastfeeding, pregnant, or planning to become pregnant during the duration of the study.
- History of eating disorder (anorexia, bulimia, binge eating disorder).
- Subjects who have taken anti-obesity medication (Orlistat) or food supplements or natural health products taken with the aim to lose weight over the 2 months prior to entry into the study.
- Prokinetic drugs cannot be started during the study period (included the follow-up period).
- The following treatments cannot be started during the study period (included the follow-up period) and the treatment with one of these treatments should be started at least 3 months prior to the beginning of the study at a stable dosage: - pharmacological treatment for dyslipidemia \[(3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (the "statins"), fibrates (gemfibrozil, clofibrate and fenofibrate), niacin/nicotinic acid, bile acid binding resins (colestipol and cholestyramine)\], antidepressant such as fluoxetine and bupropion, diuretics
Key Trial Info
Start Date :
February 26 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03423368
Start Date
February 26 2015
End Date
February 9 2018
Last Update
February 13 2018
Active Locations (1)
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1
Azienda Ospedaliera Padova
Padua, Italy, 35128