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The effect of dietary fibers and red rice extract on cholesterol level and body weight
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注册号：

Registration number：

 ChiCTR1800016300 

最近更新日期：

Date of Last Refreshed on：

 2018-05-24 21:30:59 

注册时间：

Date of Registration：

 2018-05-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effect of dietary fibers and red rice extract on cholesterol level and body weight

Public title：

The effect of dietary fibers and red rice extract on cholesterol level and body weight

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effect of dietary fibers and red rice extract on cholesterol level and body weight

Scientific title：

The effect of dietary fibers and red rice extract on cholesterol level and body weight

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Katarina Paunovic 

研究负责人：

Branko Jakovljevic 

Applicant：

Katarina Paunovic 

Study leader：

Branko Jakovljevic 

申请注册联系人电话：

Applicant telephone：

 +38 1 113612762

研究负责人电话：

Study leader's
telephone：

+38 1 113612762

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 paunkaya@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 jakovljevic@dr.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Dr Subotica 8, Belgrade, Serbia

研究负责人通讯地址：

Dr Subotica 8, Belgrade, Serbia

Applicant address：

Dr Subotica 8, Belgrade, Serbia

Study leader's address：

Dr Subotica 8, Belgrade, Serbia

申请注册联系人邮政编码：

Applicant postcode：

 11000

研究负责人邮政编码：

Study leader's postcode：

 11000

申请人所在单位：

Institute of Hygiene and Medical Ecology

Applicant's institution：

Institute of Hygiene and Medical Ecology

研究负责人所在单位：

Institute of Hygiene and Medical Ecology

Affiliation of the Leader：

Institute of Hygiene and Medical Ecology

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2650/IV-14

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

University of Belgrade, Faculty of Medicine, Ethical Committee

Name of the ethic committee：

University of Belgrade, Faculty of Medicine, Ethical Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-04-10 00:00:00

伦理委员会联系人：

Natasa Ognjanovic

Contact Name of the ethic committee：

Natasa Ognjanovic

伦理委员会联系地址：

Centre for International Collaboration, Faculty of Medicine, Dr Subotica 8, Belgrade, Serbia

Contact Address of the ethic committee：

Centre for International Collaboration, Faculty of Medicine, Dr Subotica 8, Belgrade, Serbia

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

No sponsor

Primary sponsor：

No sponsor

研究实施负责（组长）单位地址：

Not applicable

Primary sponsor's address：

Not applicable

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No funding

Source(s) of funding：

No funding

研究疾病：

Cholesterol  

Target disease：

Cholesterol

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

The objective of the study is to assess the effects of dietary fibers and red-rice extract on cholesterol level and body weight of persons with elevated cholesterol levels.  

Objectives of Study：

The objective of the study is to assess the effects of dietary fibers and red-rice extract on cholesterol level and body weight of persons with elevated cholesterol levels.

药物成份或治疗方案详述：

The participants will consume Lura Lean Cardio (registered trademark) - a dietary supplement containing dietary fibers (Konjak glukomannan, 4 gr) and red-rice extract (Monascus purpureus, 1 gr) two times per day for 45 days. The supplement will be provided in white unmarked sachets; one sachet is to be consumed 15 to 20 minutes before lunch, and the second sachet 15 to 20 minutes before dinner with two glasses of water. The participants will be advised not to change their regular eating habits and not to engage in rigorous physical activity during the course of the study. The protocol of the study includes 4 visits every 15 days. On the first visit, at baseline of the study, participants will have their blood samples taken, their body height and weight measured, body composition assessed (percent of body fat, waist circumference), and their blood pressure measured by a trained medical nurse. Participants will be informed about the objectives of the study, will give their written consent to participate and fulfill the case report form. Participants will be provided with 30 sachets of the dietary supplement to be consumed in the following 15 days. On the second visit after 15 days, the nurse will measure participants' body weight and body composition and blood pressure. Participants will fulfill a case report form and be provided with 30 sachets of the supplement. On the third visit after 30 days, the nurse will measure participants' body weight and body composition and blood pressure. Participants will fulfill a case report form and be provided with 30 sachets of the supplement. On the fourth visit after 45 days, at the end of the study, participants will have their blood samples taken for analysis, and have their body weight, body composition and blood pressure taken. They will fullfill the case report form. Participants' cholesterol levels will be measured at baseline and after 45 days of the study using standard laboratory analyses. Participants' body weight and body composition will be measured at baseline and on every subsequent visit every 15 days until the end of the study using InBody720 body composition analysis device. Participants' blood pressure will be measured using a sphygmomanometer. 

Description for medicine or protocol of treatment in detail：

The participants will consume Lura Lean Cardio (registered trademark) - a dietary supplement containing dietary fibers (Konjak glukomannan, 4 gr) and red-rice extract (Monascus purpureus, 1 gr) two times per day for 45 days. The supplement will be provided in white unmarked sachets; one sachet is to be consumed 15 to 20 minutes before lunch, and the second sachet 15 to 20 minutes before dinner with two glasses of water. The participants will be advised not to change their regular eating habits and not to engage in rigorous physical activity during the course of the study. The protocol of the study includes 4 visits every 15 days. On the first visit, at baseline of the study, participants will have their blood samples taken, their body height and weight measured, body composition assessed (percent of body fat, waist circumference), and their blood pressure measured by a trained medical nurse. Participants will be informed about the objectives of the study, will give their written consent to participate and fulfill the case report form. Participants will be provided with 30 sachets of the dietary supplement to be consumed in the following 15 days. On the second visit after 15 days, the nurse will measure participants' body weight and body composition and blood pressure. Participants will fulfill a case report form and be provided with 30 sachets of the supplement. On the third visit after 30 days, the nurse will measure participants' body weight and body composition and blood pressure. Participants will fulfill a case report form and be provided with 30 sachets of the supplement. On the fourth visit after 45 days, at the end of the study, participants will have their blood samples taken for analysis, and have their body weight, body composition and blood pressure taken. They will fullfill the case report form. Participants' cholesterol levels will be measured at baseline and after 45 days of the study using standard laboratory analyses. Participants' body weight and body composition will be measured at baseline and on every subsequent visit every 15 days until the end of the study using InBody720 body composition analysis device. Participants' blood pressure will be measured using a sphygmomanometer. 

纳入标准：

Inclusion criteria

排除标准：

1. Malignant diseases
2. Chronic kidney or liver diseases
3. Chronic bowel diseases
4. Pregnancy

Exclusion criteria：

1. Malignant diseases
2. Chronic kidney or liver diseases
3. Chronic bowel diseases
4. Pregnancy

研究实施时间：

Study execute time：

从 From 2018-06-01 00:00:00至 To 2018-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-06-01 00:00:00 至 To 2018-09-30 00:00:00

干预措施：

Interventions：

组别：

LuraLean Cardio

样本量：

 30

Group：

LuraLean Cardio

Sample size：

干预措施：

Dietary supplement

干预措施代码：

Intervention：

Dietary supplement

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Serbia

省(直辖市)：

 Serbia 

市(区县)：

 Belgrade 

Country：

Serbia

Province：

Serbia

City：

Belgrade

单位(医院)：

 Institute of Hygiene and Medical Ecology 

单位级别：

 Faculty of Medicine 

Institution
hospital：

Institute of Hygiene and Medical Ecology

Level of the institution：

Faculty of Medicine

测量指标：

Outcomes：

指标中文名：

Cholesterol

指标类型：

主要指标

Outcome：

Cholesterol

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Body weight

指标类型：

附加指标

Outcome：

Body weight

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

Blood

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Single-arm non-randomized study

Randomization Procedure (please state who generates the random number sequence and by what method)：

Single-arm non-randomized study

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Data sets with individual patient data will be made available for sharing on demand

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Data sets with individual patient data will be made available for sharing on demand

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Case report forms are created in a standardized paper form and will be analyzed using standard procedures

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case report forms are created in a standardized paper form and will be analyzed using standard procedures

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-05-24 21:31:00
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