Today is 2019-12-08

The dynamic effects of dietary patterns on lipid metabolism
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注册号:

Registration number:

ChiCTR1900027310 

最近更新日期:

Date of Last Refreshed on:

2019-11-17 

注册时间:

Date of Registration:

2019-11-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

膳食模式对机体脂代谢的动态影响 

Public title:

The dynamic effects of dietary patterns on lipid metabolism 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

膳食模式对机体脂代谢的动态影响 

Scientific title:

The dynamic effects of dietary patterns on lipid metabolism 

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:

高健 

研究负责人:

孙长颢 

Applicant:

Jian Gao 

Study leader:

Changhao Sun 

申请注册联系人电话:

Applicant telephone:

+86 18182807917 

研究负责人电话:

Study leader's telephone:

+86 13313619991 

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:

gaojianerik@126.com 

研究负责人电子邮件:

Study leader's E-mail:

542446764@qq.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:

黑龙江省哈尔滨市南岗区保健路157号 

研究负责人通讯地址:

黑龙江省哈尔滨市南岗区保健路157号 

Applicant address:

157 Baojian Road, Nangang District, Harbin, Heilongjiang 

Study leader's address:

157 Baojian Road, Nangang District, Harbin, Heilongjiang 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

哈尔滨医科大学 

Applicant's institution:

Harbin Medical University 

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:

HMUIRB2018RCT0004 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

哈尔滨医科大学医学伦理审查委员会 

Name of the ethic committee:

Medical Ethics Review Committee of Harbin Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-31 

伦理委员会联系人:

吴老师 

Contact Name of the ethic committee:

Dr. Wu 

伦理委员会联系地址:

黑龙江省哈尔滨市南岗区保健路157号 

Contact Address of the ethic committee:

157 Baojian Road, Nangang District, Harbin, Heilongjiang 

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:

哈尔滨医科大学 

Primary sponsor:

Harbin Medical University 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市南岗区保健路157号 

Primary sponsor's address:

157 Baojian Road, Nangang District, Harbin, Heilongjiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

哈尔滨医科大学

具体地址:

南岗区保健路157号

Institution
hospital:

Harbin Medical University

Address:

157 Baojian Road, Nangang District

经费或物资来源:

国家重点研发计划《中国人群脂代谢异常和动脉粥样硬化的演变过程、组学特征与分子分型》。 

Source(s) of funding:

National key research and development plan  

研究疾病:

2型糖尿病 

Target disease:

Type 2 Diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

近年来,随着经济水平的提高,人们膳食模式越来越呈现多样性的趋势。然而,不同膳食烹调方式如何影响人体内代谢谱及肠道菌群情况仍然缺少系统的分析。 本研究开展基于宏基因组和代谢组学方法研究不同膳食模式对机体脂代谢的影响研究,并通过随机对照试验研究不同烹调方式对健康机体代谢全谱及肠道菌群的动态影响。 

Objectives of Study:

In recent years, with the improvement of the economic level, people's dietary patterns have become more and more diverse. However, how different dietary cooking methods affect the metabolic profile of the human body and the intestinal flora remains a lack of systematic analysis. This study was conducted to study the effects of different dietary patterns on lipid metabolism in the body based on metagenomics and metabolomics methods, and to study the dynamic effects of different cooking methods on the full spectrum of healthy body and intestinal flora through randomized controlled trials. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄18至30岁的哈尔滨医科大学社区居民; 2. 肝肾功能正常,谷丙转氨酶(ALT)、谷草转氨酶(AST)、AST/ALT、血清肌酐(Cre)、尿酸(UA)、尿素和尿素氮(BUN)水平正常; 3. 血脂水平正常,总胆固醇(TCHO)、甘油三脂(TG)、高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C); 4. 已经签署知情同意书。 

Inclusion criteria

1. Community residents of Harbin Medical University aged 18 to 30 years; 2. Normal liver and kidney function, normal levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), AST/ALT, serum creatinine (Cre), uric acid (UA), urea and urea nitrogen (BUN); 3. Normal blood lipid levels, total cholesterol (TCHO), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C); 4. Informed consent has been signed. 

排除标准:

1. 有手术史或其他严重创伤史; 2. 有急、慢性病或传染性疾病; 3. 贫血:男性Hb<120g/L,成年女性(非妊娠)Hb<110g/L; 4. 血压异常者; 5. 过去2个月内有服用药物、保健品或维生素; 6. 过去6个月内有通过节食、药物等方式减肥者; 7. 有饮酒或吸烟习惯; 8. 有特殊饮食习惯的(如挑食、素食者),或消化系统疾病,如胃炎、胆囊炎、十二指肠溃疡等; 9. 剧烈体力活动者,每周>5h; 10. 有海鲜等食物过敏史。 

Exclusion criteria:

1. Have a history of surgery or other serious traumatic history; 2. Acute, chronic or infectious diseases; 3. Anemia, male Hb <120g / L, adult female (non-pregnant) Hb <110g / L; 4. Abnormal blood pressure; 5. Have taken medication, health supplements or vitamins in the past 2 months; 6. In the past 6 months, people who have lost weight through dieting, drugs, etc.; 7. Have drinking or smoking habits; 8. Have special dietary habits (such as picky eaters, vegetarians), or digestive diseases such as gastritis, cholecystitis, duodenal ulcers, etc.; 9. Severe physical activity, >5h per week; 10. Have a history of food allergies such as seafood. 

研究实施时间:

Study execute time:

From2019-11-01To 2019-12-09 

干预措施:

Interventions:

组别:

低温烹饪组

样本量:

70

Group:

Low-Group

Sample size:

干预措施:

低温烹饪

干预措施代码:

Intervention:

Low temperature cooking

Intervention code:

组别:

高温烹饪组

样本量:

70

Group:

High-Group

Sample size:

干预措施:

高温烹饪

干预措施代码:

Intervention:

High temperature cooking

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨医科大学 

单位级别:

大学 

Institution
hospital:

Harbin Medical University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

High

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

Glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素

指标类型:

主要指标 

Outcome:

Insulin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

HbA1c

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

饥饿素

指标类型:

次要指标 

Outcome:

Human GHRL

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘦素

指标类型:

次要指标 

Outcome:

Human Leptin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C肽

指标类型:

次要指标 

Outcome:

C-Peptide

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人成纤维细胞成长因子-21

指标类型:

次要指标 

Outcome:

FGF-21

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人脂多糖结合蛋白

指标类型:

次要指标 

Outcome:

LBP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人可溶性白细胞分化抗原14

指标类型:

次要指标 

Outcome:

sCD14

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人晚期糖基化终末产物

指标类型:

次要指标 

Outcome:

AGEs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人脂联素

指标类型:

次要指标 

Outcome:

ADP

Type:

Secondary 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:

血液

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:

尿液

组织:

Sample Name:

Urine

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:

粪便

组织:

Sample Name:

Feces

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 30 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):

由专门的随机实施人员采用SPSS 22.0统计软件生成随机分配序列。该人员不参与入组,干预,评定和统计分析等过程。

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

Randomly assigned sequences were generated by a dedicated random implementation using SPSS 22.0 statistical software. This person does not participate in the process of enrollment, intervention, assessment and statistical analysis.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

试验完成6个月之后,在我院网站上公开或者向研究者索取。

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

After the test is completed for 6 months, it will be published on our website or request research data from the researcher.

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:

研究者及结局指标观察者根据研究对象的原始观察记录,将研究数据及时,完整,正确,清晰地填入CRF表,并经临床研究监察员审核,签字后及时移交数据管理员

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

The researcher and the observer of the outcome indicator will fill the CRF form in a timely, complete, correct and clear manner according to the original observation record of the research object, and will be reviewed by the clinical research supervisor, signed and transferred to the data manager in time.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-08
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