Assessment of the Effects of Policaptil Gel Retard® on the Glycemic, Lipid and Weight Profile in Overweight and Mild Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Assessment of changes in the postprandial glycemic profile - V4 versus V3 - fasting insulin
研究概览
简要总结
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 weight profile in overweight and mild obese subjects
详细描述
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 collect information regarding the medical history, the demography, the concomitant medications. The eligibility criteria (inclusion and exclusion criteria) will be verified and during this visit the subjects who will meet the eligibility criteria will be enrolled after the signature of the informed consent form. Each subject will be informed verbally and in writing about the nature and all the requirements of the study.
A brief clinical examination will be performed, including evaluation of vital signs (pulse, systolic and diastolic pressure) and anthropometric parameters (body weight, height, BMI, waist circumference, waist-to-hip and waist-to-height ratio).
Blood and urine samples will be collected for safety routine analysis and for specific analysis to test liver and kidney functionality, glycemic and lipid profile (i.e. glycemic / lipid markers values). An Oral Glucose Tolerance Test (OGTT) will be also performed.
A diary will be given to each subject to record their daily food intake (they will be asked to avoid some food and food supplements/ingredients) and physical activity.
The next visit will be scheduled after 15 days. V2 (day -10) - postprandial metabolic profile short-term assessment - Policaptil Gel Retard® intake During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; a confirmation of eligibility will take place, on the basis of laboratory tests results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 - 60 years old (18 and 60 included).
- •BMI ≥ 25 Kg/m2 and ≤ 34.9 Kg/m
- •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.
排除标准
- •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
研究组 & 干预措施
Libramed
Each patient will be admistered 6 tablets/day (3 tablets before lunch, 3 tablets before dinner) of Libramed for 30 days
干预措施: Libramed (Device)
Placebo
Each patient will be admistered 6 tablets/day (3 tablets before lunch, 3 tablets before dinner) of placebo for 30 days
干预措施: Placebo (Device)
结局指标
主要结局
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - fasting insulin
时间窗: day 30 Vs. day 0
HOMA index and HbA1c values evaluation
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HOMA index
时间窗: day 30 Vs. day 0
HOMA index
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - OGTT
时间窗: day 30 Vs. day 0
OGTT
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HbA1c
时间窗: day 30 Vs. day 0
HbA1c
次要结局
- Anthropometric parameters - body weight(day 30 Vs. day 0)
- Anthropometric parameters - waist-to-height ratio(day 30 Vs. day 0)
- Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - fasting insulin(day -10 Vs. day 0)
- Anthropometric parameters - BMI(day 30 Vs. day 0)
- Anthropometric parameters - waist-to-hip ratio(day 30 Vs. day 0)
- Dual energy X-ray absorptiometry - V4 versus V3(day 30 Vs. day 0)
- Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HbA1c(day -10 Vs. day 0)
- Anthropometric parameters -Waist circumference(day 30 Vs. day 0)
- Systolic /diastolic blood pressure - V4 versus V3(day 30 Vs. day 0)
- Postprandial lipid profile - V4 versus V3(day 30 Vs. day 0)
- Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - OGTT(day -10 Vs. day 0)
- Feeling of hunger and feeling of appetite - V4 versus V3(day 30 Vs. day 0)
- Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HOMA index(day -10 Vs. day 0)
- Postprandial lipid profile after a single consumption of the product - V2 versus V3(day -10 Vs. day 0)