ChiCTR2500102879 版本V1.0 版本创建时间2025/05/21 10:56:07 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500102879 

最近更新日期：

Date of Last Refreshed on：

2025-05-21 10:56:01 

注册时间：

Date of Registration：

2025-05-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Taurine Or Placebo for Healthcare Workers: the TOP Healthcare workers' Bayesian Optimized Phase II randomised-controlled trial

Public title：

Taurine Or Placebo for Healthcare Workers: the TOP Healthcare workers' Bayesian Optimized Phase II randomised-controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Taurine Or Placebo for Healthcare Workers: the TOP Healthcare workers' Bayesian Optimized Phase II randomised-controlled trial

Scientific title：

Taurine Or Placebo for Healthcare Workers: the TOP Healthcare workers' Bayesian Optimized Phase II randomised-controlled trial

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：

Pik Yi HOU 

研究负责人：

Kwok Ming HO 

Applicant：

Pik Yi HOU 

Study leader：

Kwok Ming HO 

申请注册联系人电话：

Applicant telephone：

+852 3505 1907

研究负责人电话：

Study leader's telephone：

+852 3505 1312

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：

gracehou@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

kmho@cuhk.edu.hk

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：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong

研究负责人通讯地址：

Office 21, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Applicant address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Study leader's address：

Office 21, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

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：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

Applicant's institution：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024.337-T

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：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2024-09-13 00:00:00

伦理委员会联系人：

Amy Li

Contact Name of the ethic committee：

Amy Li

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3505 3935

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong

Primary sponsor's address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong

Institution
hospital：

The Chinese University of Hong Kong

Address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong

经费或物资来源：

Department internal funding

Source(s) of funding：

Department internal funding

Target disease：

None

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To assess whether oral taurine supplementation will improve metabolic health of healthcare workers.  

Objectives of Study：

To assess whether oral taurine supplementation will improve metabolic health of healthcare workers.

药物成份或治疗方案详述：

Taurine capsules produced by Optima Ovest, the company from the Western Australia. The identical-looking placebo is a proprietary product from Coloron called StarCap. Placebo capsule is a mixture of pregelatinized maize starch and maize starch.  

Description for medicine or protocol of treatment in detail：

Taurine capsules produced by Optima Ovest, the company from the Western Australia. The identical-looking placebo is a proprietary product from Coloron called StarCap. Placebo capsule is a mixture of pregelatinized maize starch and maize starch.  

纳入标准：

Healthcare related workers who can read and understand English or Chinese translated version of the study questionnaires will be invited to participate including doctors, nurses, physiotherapists, dietitians, or research-related workers at the New Territories East Cluster Hospitals

Inclusion criteria

Healthcare related workers who can read and understand English or Chinese translated version of the study questionnaires will be invited to participate including doctors, nurses, physiotherapists, dietitians, or research-related workers at the New Territories East Cluster Hospitals

排除标准：

(a)Are taking taurine prior to enrolment, (b) Have chronic renal disease (eGFR<30ml/min: as taurine can accumulate in renal failure) (c) Insulin-dependent diabetes mellitus (d) A bleeding disorder (e.g. platelet count < 100x10^9/L or treated with dual antiplatelet agents: as taurine has potential antiplatelet activity in vitro) (e) Received active chemo/immunotherapy < 30 days before enrolment or likely to receive such treatment during the study (f) Pregnant or planning to become pregnant

Exclusion criteria：

(a)Are taking taurine prior to enrolment, (b) Have chronic renal disease (eGFR<30ml/min: as taurine can accumulate in renal failure) (c) Insulin-dependent diabetes mellitus (d) A bleeding disorder (e.g. platelet count < 100x10^9/L or treated with dual antiplatelet agents: as taurine has potential antiplatelet activity in vitro) (e) Received active chemo/immunotherapy < 30 days before enrolment or likely to receive such treatment during the study (f) Pregnant or planning to become pregnant

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2027-12-08 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-07-01 00:00:00 至 To 2027-12-08 00:00:00  

干预措施：

Interventions：

组别：

Treatment group

样本量：

40

Group：

Treatment group

Sample size：

干预措施：

Participant will take oral taurine (3g/day) or identical looking placebo over a 6-month period. All participants will need to complete questionnaires i.e. Center for Epidemiologic Studies Depression Scale (CES-D) and International Physical Activity Questionnaire (IPAQ). All participants will have blood tests for blood glycated haemoglobin (HbA1c), low-density-lipoprotein (LDL), triglyceride, and methylglyoxal concentrations, biological age as quantified by the Levine PhenoAge model, skin autofluorescence index. Their blood pressure and body weight will also be recorded. Changes in gut microbiome for an 8-patient subgroup constitutes the tertiary outcome

干预措施代码：

Intervention：

Participant will take oral taurine (3g/day) or identical looking placebo over a 6-month period. All participants will need to complete questionnaires i.e. Center for Epidemiologic Studies Depression Scale (CES-D) and International Physical Activity Questionnaire (IPAQ). All participants will have blood tests for blood glycated haemoglobin (HbA1c), low-density-lipoprotein (LDL), triglyceride, and methylglyoxal concentrations, biological age as quantified by the Levine PhenoAge model, skin autofluorescence index. Their blood pressure and body weight will also be recorded. Changes in gut microbiome for an 8-patient subgroup constitutes the tertiary outcome

Intervention code：

组别：

Placebo group

样本量：

40

Group：

Placebo group

Sample size：

干预措施：

Participant will take identical looking placebo orally over a 6-month period. All participants will need to complete questionnaires i.e. Center for Epidemiologic Studies Depression Scale (CES-D) and International Physical Activity Questionnaire (IPAQ). All participants will have blood tests for blood glycated haemoglobin (HbA1c), low-density-lipoprotein (LDL), triglyceride, and methylglyoxal concentrations, biological age as quantified by the Levine PhenoAge model, skin autofluorescence index. Their blood pressure and body weight will also be recorded. Changes in gut microbiome for an 8-patient subgroup constitutes the tertiary outcome

干预措施代码：

Intervention：

Participant will take identical looking placebo orally over a 6-month period. All participants will need to complete questionnaires i.e. Center for Epidemiologic Studies Depression Scale (CES-D) and International Physical Activity Questionnaire (IPAQ). All participants will have blood tests for blood glycated haemoglobin (HbA1c), low-density-lipoprotein (LDL), triglyceride, and methylglyoxal concentrations, biological age as quantified by the Levine PhenoAge model, skin autofluorescence index. Their blood pressure and body weight will also be recorded. Changes in gut microbiome for an 8-patient subgroup constitutes the tertiary outcome

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China 

Province：

Hong Kong 

City：

 

单位(医院)：

Prince of Wales Hospital 

单位级别：

Tertiary 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China 

Province：

Hong Kong 

City：

 

单位(医院)：

North District Hospital 

单位级别：

Tertiary 

Institution
hospital：

North District Hospital

Level of the institution：

Tertiary

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China 

Province：

Hong Kong 

City：

 

单位(医院)：

Alice Ho Miu Ling Hospital 

单位级别：

Tertiary 

Institution
hospital：

Alice Ho Miu Ling Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

HbA1c

指标类型：

主要指标

Outcome：

HbA1c

Type：

Primary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

LDL and triglyceride levels

指标类型：

次要指标

Outcome：

LDL and triglyceride levels

Type：

Secondary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

PhenoAge

指标类型：

次要指标

Outcome：

PhenoAge

Type：

Secondary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

指标中文名：

Body weight

指标类型：

次要指标

Outcome：

Body weight

Type：

Secondary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

指标中文名：

IPAQ

指标类型：

次要指标

Outcome：

IPAQ

Type：

Secondary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

International Physical Activity Questionnaire

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

International Physical Activity Questionnaire

指标中文名：

Blood pressure

指标类型：

次要指标

Outcome：

Blood pressure

Type：

Secondary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

指标中文名：

Center for Epidemiologic Studies Depression Scale

指标类型：

次要指标

Outcome：

Center for Epidemiologic Studies Depression Scale

Type：

Secondary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

指标中文名：

AGEs index

指标类型：

次要指标

Outcome：

AGEs index

Type：

Secondary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Skin autofluorescence technology

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Skin autofluorescence technology

指标中文名：

Differences in gut microbiome

指标类型：

附加指标

Outcome：

Differences in gut microbiome

Type：

Additional indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Compare gut microbiota diversity using fecal samples

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Compare gut microbiota diversity using fecal samples

指标中文名：

Albumin

指标类型：

附加指标

Outcome：

Albumin

Type：

Additional indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

Creatinine

指标类型：

附加指标

Outcome：

Creatinine

Type：

Additional indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

C-reactive protein

指标类型：

附加指标

Outcome：

C-reactive protein

Type：

Additional indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

Complete blood count

指标类型：

附加指标

Outcome：

Complete blood count

Type：

Additional indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

Alkaline phsphatase

指标类型：

附加指标

Outcome：

Alkaline phosphatase

Type：

Additional indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

Methylglyoxal level

指标类型：

主要指标

Outcome：

Methyglyoxal level

Type：

Primary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

指标中文名：

Plasma taurine level

指标类型：

主要指标

Outcome：

Plasma taurine level

Type：

Primary indicator

测量时间点：

At 6 month follow-up from baseline

测量方法：

Blood test

Measure time point of outcome：

At 6 month follow-up from baseline

Measure method：

Blood test

采集人体标本：

Collecting sample(s)
from participants：

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：

标本中文名：

Stool

组织：

Sample Name：

Stool

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 岁 years
最大 Max age 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）：

Randomization and data capture will be through the RedCap.

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

Randomization and data capture will be through the RedCap.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Everyone will be blinded to the study capsules - maybe except the company that manufactures the study capsules in Western Australia. Bottle will be labelled as A or B (with certain serial study number).

Blinding：

Everyone will be blinded to the study capsules - maybe except the company that manufactures the study capsules in Western Australia. Bottle will be labelled as A or B (with certain serial study numbers).

是否共享原始数据：

IPD sharing

No

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）：

None

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

None

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-05-21 10:56:01