Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects: POSO Study (Polyglucosamine and Overweight)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
The purpose of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
详细描述
The primary objective of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
The secondary objectives of the study are:
- to evaluate the effect of supplementation on blood triglyceride levels
- to evaluate the effect of supplementation on blood levels of Total Cholesterol (CT), LDL, and HDL
- to evaluate the effect of supplementation on glucose, insulin, insulin resistance assessed by calculating the Homeostatic metabolic assessment (HOMA)
- to evaluate the effect of supplementation on liver enzymes (transaminases) and renal function (creatinine)
- to evaluate the effect of supplementation on BMI (Body Mass Index)
- to evaluate the effect of supplementation on the abdominal circumference
- to evaluate the effect of supplementation on body composition evaluated by dual X-ray densitometer (DXA)
- to evaluate the effect of supplementation on the serum levels of reactive oxygen species
- to evaluate the effect of supplementation on serum antioxidant capacity
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent
- •Age between 18-65
- •Both sexes - mandatory adequate contraceptive method for women in fertility age
- •BMI between 25-32 kg/m2 and weigh in > 75 kg, with no previous diet-therapy attempts with at least a 5% weight loss in the last year
- •No 3 kg weight fluctuation in the last 3 months
- •Beck Depression Inventory (BDI) score < 20
- •Binge Eating Scale (BES) score < 27
排除标准
- •Shellfish allergy or to any other ingredient in the product
- •Previous diet-therapy attempts with at least a 5% weight loss in the last year
- •3 kg weight fluctuation in the last 3 months
- •Presumed or confirmed pregnancy
- •No contraceptive method for women in fertility age
- •Cardiopathies, nephropathies, hepatopathies, bronchopneumopathies, hemopathies dermopathies clinically significant chronic degenerative CNS (Central Nervous System) diseases
- •Active peptic ulcer, ulcerative colitis, Crohn disease, celiac disease, inflammatory bowel disease
- •Alcoholism
- •Past or current malignancies
- •Intellectual disability
- •Significant motor disability
- •Drug abuse
- •Autoimmune diseases
- •Symptomatic cholelithiasis
研究组 & 干预措施
Product
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg
干预措施: Polyglucosamine L112 (Drug)
Placebo
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg
干预措施: Placebo (Other)
结局指标
主要结局
Weight Loss
时间窗: 3-month treatment
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
次要结局
- Triglycerides(3-month treatment)
- Cholesterol(3-month treatment)
- HOMA(3-month treatment)
- Hepatic Enzymes - Renal Functionality(3-month treatment)
- BMI(3-month treatment)
- Abdominal Circumference(3-month treatment)
- DXA(3-month treatment)
- ROS(3-month treatment)
- Antioxidant Serum Capacity(3-month treatment)