A Study to Evaluate the Efficacy and the Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers: a Randomized, Double-blind, Parallel Groups and Placebo Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kitozyme
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The prevalence of overweight and obesity is getting more and more important in developed as well as in emerging countries. It can be defined according to the degree of fat storage by measurement of fat mass.
No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a fungal chitosan from the mycelium of non-genetically modified Aspergillus niger. KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan.
The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body weight reduction after 3 months of intake in overweight and obese men and women. Furthermore, effects on anthropometric measurements, body fat mass percentage, serum lipids and safety parameters will be investigated.
详细描述
The study duration per subject will be 3 months and 1 week maximum. Subjects will be screened at visit V1 and will start a 1-week run-in period, during which subjects will ingest 2 capsules of placebo 3 times a day.
The subjects will then be randomized to receive the investigational medical device or placebo (1:1) for a 3 months product intake period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females volunteers, able to read and write.
- •Subject with 25 ≤ Body Mass Index ≤ 35 kg/m².
- •Subject with a good physical condition based on the subject's interview and the clinical exam performed by the Investigator.
- •Subject with stable body weight (< 5% variation) within the last 3 months prior to screening (based on interview).
- •Written informed consent provided prior to screening, after receiving and understanding the subject information.
- •Subject willing to lose weight.
- •Subject accepting to follow diet and lifestyle instructions throughout the study.
- •Subject willing to take study capsules three times a day for 3 months and 1 week and undergo other study-related procedures.
- •Registered with the French Social Security, in agreement with the French law on biomedical experimentation.
排除标准
- •Smoker or former smoker having stopped within 2 months prior to screening visit.
- •Subject with a history of alcohol or drug abuse.
- •Subject with physical activity more than 3 hours per week.
- •Subject with any sensitivity or allergy to any of the products used within this clinical trial.
- •Subject with history of eating disorder (anorexia nervosa, bulimia nervosa).
- •Subject having used weight reduction treatments or products during the last 3 months prior to screening visit.
- •Subject with significant gastrointestinal disease (e.g. coeliac disease, pancreatitis), signs of intestinal obstruction or medical history of constipation.
- •Intake of chronic medication which could interfere with study parameters (weight, appetite, satiety, lipid blood levels, glycemia, gastrointestinal function), having an effect on digestion or absorption of nutrients, excepted oestroprogestative or progestative contraception started at least three months before the screening visit.
- •Female subject planning a pregnancy, pregnant or breastfeeding.
- •Female subject without efficient contraceptive method.
- •Subject with history of bariatric surgery.
- •Subject with known systemic disease such as cancer, human immunodeficiency virus (HIV) seropositivity.
- •Subject with type 1 or type 2 diabetes mellitus.
- •Subject with history of significant medical or surgical event requiring hospitalization during the 3 months prior the screening visit.
- •Subject having, had or scheduling to have an exam that uses barium, a radioisotope injection, or oral or intravenous contrast material within 2 weeks prior screening visit and during the study.
- •Participation to any other clinical trial simultaneously and/or within 1 month prior the screening visit.
- •Subject who has donated blood or blood products within the previous month prior to screening or who plans to donate blood or blood products at any time during the trial and in the 3 months following the end of the study.
- •Subject judged unlikely to comply with study product intake (screening compliance < 80%) and with diet and lifestyle instructions.
结局指标
主要结局
Body weight
时间窗: 0 ; 30 ; 60 ; 90 days
Comparison of the reduction of body weight, from baseline (randomization visit) to end-point (3 months of treatment), between KiOnutrime®-Cs and placebo arms.
次要结局
- Gastrointestinal tolerance(-7 ; 0 ; 30 ; 60 ; 90 days)
- Adverse events(Study duration)
- Body fat mass(0 - 90 days)
- Hunger and satiety sensation(-7 ; 0 ; 30 ; 60 ; 90 days)
- Electrolytic measurements and fat-soluble vitamins(0 - 90 days)
- Physical Activity score(-7 ; 0 ; 30 ; 60 ; 90 days)
- Anthropometric measurements(0 ; 30 ; 60 ; 90 days)
- Serum lipids(0 - 90 days)
- Safety blood parameters(0 - 90 days)
- Food recording(0 ; 30 ; 60 ; 90 days)
- Blood pressure(0 ; 30 ; 60 ; 90 days)