ChiCTR2500111606 版本V1.0 版本创建时间2025/11/03 17:13:51 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：

ChiCTR2500111606 

最近更新日期：

Date of Last Refreshed on：

2025-11-03 17:13:45 

注册时间：

Date of Registration：

2025-11-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The Effect of 5:2 Diet Combined with Multicomponent Structured Exercise on Physiological and Psychological ni Older Adults with Abdominal Obese

Public title：

The Effect of 5:2 Diet Combined with Multicomponent Structured Exercise on Physiological and Psychological ni Older Adults with Abdominal Obese

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The Effect of 5:2 Diet Combined with Multicomponent Structured Exercise on Physiological and Psychological ni Older Adults with Abdominal Obese

Scientific title：

The Effect of 5:2 Diet Combined with Multicomponent Structured Exercise on Physiological and Psychological ni Older Adults with Abdominal Obese

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：

Zhang Haiqin 

研究负责人：

Zhang Haiqin 

Applicant：

Zhang Haiqin 

Study leader：

Zhang Haiqin 

申请注册联系人电话：

Applicant telephone：

+852 5338 3241

研究负责人电话：

Study leader's telephone：

+852 2948 7854

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：

s1154538@s.eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

s1154538@s.eduhk.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：

The Education University Of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

研究负责人通讯地址：

The Education University Of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

Applicant address：

The Education University Of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

Study leader's address：

The Education University Of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

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：

The Education University of Hong Kong

Applicant's institution：

The Education University of Hong Kong

研究负责人所在单位：

The Education University of Hong Kong

Affiliation of the Leader：

The Education 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：

2024-2025-0709

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：

Human Research Ethics Committee

Name of the ethic committee：

Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-09-12 00:00:00

伦理委员会联系人：

Mr Desmond Kwok

Contact Name of the ethic committee：

Mr Desmond Kwok

伦理委员会联系地址：

The Education University of Hong Kong c/o Research and Development Office 10 Lo Ping Road, Tai Po , Hong Kong

Contact Address of the ethic committee：

The Education University of Hong Kong, 10 Lo Ping Road, Tai Po , Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 2948 8614

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 Education University of Hong Kong

Primary sponsor：

The Education University of Hong Kong

研究实施负责（组长）单位地址：

The Education University of Hong Kong,10 Lo Ping Road, Tai Po , Hong Kong

Primary sponsor's address：

The Education University of Hong Kong,10 Lo Ping Road, Tai Po , Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Hong Kong

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Education University of Hong Kong

具体地址：

The Education University of Hong Kong,10 Lo Ping Road, Tai Po , Hong Kong

Institution
hospital：

The Education University of Hong Kong

Address：

The Education University of Hong Kong,10 Lo Ping Road, Tai Po , Hong Kong

经费或物资来源：

The Education University of Hong Kong

Source(s) of funding：

The Education University of Hong Kong

Target disease：

Abdominal Obese

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：

Aims of the study is to examine the efficacy of combined 5:2 diet and multicomponent structured exercise (MSE) versus single interventions on body composition and metabolic parameters in older populations, while simultaneously evaluating intervention feasibility in this demographic.  

Objectives of Study：

Aims of the study is to examine the efficacy of combined 5:2 diet and multicomponent structured exercise (MSE) versus single interventions on body composition and metabolic parameters in older populations, while simultaneously evaluating intervention feasibility in this demographic.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Age >=60 years 2. Body mass index >=25 kg/m^2, with waist circumference (WC) >80 cm for women, >90 cm for men. 3. Physically inactive 4. Weight stability (<5% fluctuation over previous 3 months)

Inclusion criteria

1. Age >=60 years 2. Body mass index >=25 kg/m^2, with waist circumference (WC) >80 cm for women, >90 cm for men. 3. Physically inactive 4. Weight stability (<5% fluctuation over previous 3 months)

排除标准：

1. Diagnosed serious cardiovascular or metabolic diseases 2. Medical contraindications to exercise participation 3. Current enrollment in other dietary intervention programs within the previous 90 days 4. Use of medications affecting metabolism or body weight

Exclusion criteria：

1. Diagnosed serious cardiovascular or metabolic diseases 2. Medical contraindications to exercise participation 3. Current enrollment in other dietary intervention programs within the previous 90 days 4. Use of medications affecting metabolism or body weight

研究实施时间：

Study execute time：

从 From 2025-10-27 00:00:00至 To 2026-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-11-03 00:00:00 至 To 2025-12-31 00:00:00  

干预措施：

Interventions：

组别：

Control group

样本量：

30

Group：

Control group

Sample size：

干预措施：

Participants randomized to the control group will be asked to maintain their habitual activities without receiving any structured dietary or exercise interventions.

干预措施代码：

Intervention：

Participants randomized to the control group will be asked to maintain their habitual activities without receiving any structured dietary or exercise interventions.

Intervention code：

组别：

5:2 diet group

样本量：

30

Group：

5:2 diet group

Sample size：

干预措施：

Participants allocated to the 5:2 diet group (5:2 group) will be received a structured dietary program for 14 weeks. The implementation involves two non-consecutive fasting days per week (Tuesday and Thursday) with a caloric progression of 1000 kcal/day in week 1, 800 kcal/day in week 2, and 500 kcal/day for female and 600 kcal/day for male from week 3 onward. Macronutrient composition of 50% carbs, 30% protein, 20% fat, while the remaining five days allow for ad libitum eating.

干预措施代码：

Intervention：

Participants allocated to the 5:2 diet group (5:2 group) will be received a structured dietary program for 14 weeks. The implementation involves two non-consecutive fasting days per week (Tuesday and Thursday) with a caloric progression of 1000 kcal/day in week 1, 800 kcal/day in week 2, and 500 kcal/day for female and 600 kcal/day for male from week 3 onward. Macronutrient composition of 50% carbs, 30% protein, 20% fat, while the remaining five days allow for ad libitum eating.

Intervention code：

组别：

Multicomponent structured exercise group

样本量：

30

Group：

Multicomponent structured exercise group

Sample size：

干预措施：

Participants allocated to the MSE group will be asked to complete a supervised, periodized exercise program. The 14-week exercise intervention consisted of three weekly 70-minute sessions conducted on non-consecutive days (Monday, Wednesday, Friday) with the following structure:1. Warm-up (5 min); cool-down (5 min), 2. Primary training (60 min): a) Aerobic session (25 min), b) Resistance session (25 min), c) Balance training (10 min).

干预措施代码：

Intervention：

Participants allocated to the MSE group will be asked to complete a supervised, periodized exercise program. The 14-week exercise intervention consisted of three weekly 70-minute sessions conducted on non-consecutive days (Monday, Wednesday, Friday) with the following structure:1. Warm-up (5 min); cool-down (5 min), 2. Primary training (60 min): a) Aerobic session (25 min), b) Resistance session (25 min), c) Balance training (10 min).

Intervention code：

组别：

5:2 diet + MSE group

样本量：

30

Group：

5:2 diet + MSE group

Sample size：

干预措施：

Intervention descipted as in 5:2 diet + Intervention descipted as in MSE

干预措施代码：

Intervention：

Intervention descipted as in 5:2 diet + Intervention descipted as in MSE

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)：

The Education University of Hong Kong 

单位级别：

University 

Institution
hospital：

The Education University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Body weigh

指标类型：

主要指标

Outcome：

Body weigh

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Waist circumference

指标类型：

主要指标

Outcome：

Waist circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Muscle mass

指标类型：

主要指标

Outcome：

Muscle mass

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Fat mass

指标类型：

次要指标

Outcome：

Fat mass

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Serum lipids

指标类型：

次要指标

Outcome：

Serum lipids

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Systolic and diastolic blood pressure

指标类型：

次要指标

Outcome：

Systolic and diastolic blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Serum glucose

指标类型：

次要指标

Outcome：

Serum glucose

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Serum insulin

指标类型：

次要指标

Outcome：

Serum insulin

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cytokines

指标类型：

次要指标

Outcome：

Cytokines

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Habitual physical activity

指标类型：

次要指标

Outcome：

Habitual physical activity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Physical functions

指标类型：

次要指标

Outcome：

Physical functions

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Sleep

指标类型：

次要指标

Outcome：

Sleep

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

EQ-5D-5L questionnaires

指标中文名：

Cognitive function

指标类型：

次要指标

Outcome：

Cognitive function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Gut microbiota

指标类型：

次要指标

Outcome：

Gut microbiota

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Satiety

指标类型：

次要指标

Outcome：

Satiety

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Hungry and Satisfied Visual Scales, VAS

指标中文名：

Grip strength

指标类型：

次要指标

Outcome：

Grip strength

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The lower extremity strength

指标类型：

次要指标

Outcome：

The lower extremity strength

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Balance

指标类型：

次要指标

Outcome：

Balance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Aerobic capacity

指标类型：

次要指标

Outcome：

Aerobic capacity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Visceral fat

指标类型：

次要指标

Outcome：

Visceral fat

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Hip circumference

指标类型：

次要指标

Outcome：

Hip circumference

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 reactive protine

指标类型：

次要指标

Outcome：

C reactive protine

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：

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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 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）：

A random sequence will be generated by designated individual via computer prior to participant enrollment to determine group assignments.

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

A random sequence will be generated by designated individual via computer prior to participant enrollment to determine group assignments.

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：

Single-blind (Outcomes Assessor)

Blinding：

Single-blind (Outcomes Assessor)

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

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：

  2025-11-03 17:13:45