NCT05022732已完成不适用
Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device Based on Polyglucosamine L112® in a Group of Overweight and Obese Subjects
Azienda di Servizi alla Persona di Pavia2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Changes on anthropometric measures
研究概览
简要总结
This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day 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
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
- •weight > 75 Kg
- •absence of previous diet therapy attempts
- •no fluctuation of at least 3 kg in the previous 3 months
- •Beck Depression Inventory score < 20 pt
- •Binge Eating Scale score < 27 pt
排除标准
- •allergy to shellfish
- •pregnancy or breast feeding
- •presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System
- •presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease
- •symptomatic cholelithiasis
- •previous or current neoplasms
- •obesity secondary to endocrinopathies or genetic syndromes
- •significant motor disability or mental retardation
- •major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), schizophrenia
- •previous history or current diagnosis of drug abuse or alcoholism
- •changing in smoking habits or quitting smoking in the last 6 months
- •current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite
结局指标
主要结局
Changes on anthropometric measures
时间窗: Changes from baseline anthropometric measures at 90 days
Body weight (Kg)
次要结局
- Changes on lipid profile(Changes from baseline lipid profile at 90 days)
- Changes on insulin resistance(Changes from baseline insulin resistance at 90 days)
- Changes on body composition(Changes from baseline body composition at 90 days)
- Changes on oxidative stress(Changes from baseline oxidative stress at 90 days)
- Changes on Carbohydrate profile(Changes from baseline Carbohydrate profile at 90 days)
- Changes on safety(Changes from baseline safety at 90 days)
- Changes on anthropometric measures(Changes from baseline anthropometric measures at 90 days)
研究者
研究点 (2)
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