Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00569

2 Trial Registration Date

2017-11-03

i Registration Status

Prospective

3 Secondary IDs

U1111-1205-5691

4 Source(s) of Funding

No

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Waris Wongpipit

ii Address

G02, Kwok Sports Building, Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR

iii Phone

59678896

iv Email

waris.w@link.cuhk.edu.hk

v Affiliation

Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Waris Wongpipit

ii Address

G02, Kwok Sports Building, Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR

iii Phone

59678896

iv Email

waris.w@link.cuhk.edu.hk

v Affiliation

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Breaking up Prolonged Sitting with Light-intensity Walking and Sitting Bouts Duration on Postprandial Metabolic Responses in Overweight/Obese Male Adults

10 Public Title

Breaking up Prolonged Sitting with Light-intensity Walking and Sitting Bouts Duration on Postprandial Metabolic Responses in Overweight/Obese Male Adults

i Public Title in Chinese 研究名稱

N/A

11 Short Title (Optional)

Breaking up Prolonged Sitting and Postprandial Metabolic Responses in Overweight/Obese Men

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-10-18

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC-2017.435

14 Medical Condition Being Studied

Overweight/Obesity

15 Intervention

i Types of intervention

Other

Please specify

Exercise

ii Description/ name of Intervention/article

Light-intensity walking at 3.2 km/h on a treadmill for 6 minutes every 60 minutes of sitting.

iii Dosage form of the intervention

Duration and frequency of breaking up prolonged sitting

iv Dosage of the intervention

30 minutes

v Duration of the intervention

6 hours

vi Frequency of the intervention

5 times over 6 hours

16 Comparative Treatments

i Description/ name of comparative treatments

Light-intensity walking at 3.2 km/h on a treadmill for 3 minutes every 30 minutes of sitting.

ii Dosage form of the comparative treatments

Duration and frequency of breaking up prolonged sitting

iii Dosage of the comparative treatments

30 minutes

iv Duration of the comparative treatments

6 hours

v Frequency of the comparative treatments

10 times over 6 hours

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Chinese men aged between 18 and 34 years

With overweight/obesity (Body Mass Index is higher than 22.9 km/m^2)

Total time spent sitting is more than 5 hours per day

Fluent in English

Physically Inactive (No exercise)

ii Exclusion Criteria

Allergic to milk or gluten

With history of cardiovascular disease and/or diabetes

Fasting blood glucose is over than 7 mmol/L, and/or 2-hour postprandial glucose in the 75-g Oral glucose tolerance test is over than 199 mg/dL, and/or HbA1C is over than 6.4%

Smoker

With conditions that alter limit capability to walk on a treadmill

Taking any medications known to affect lipid or glucose metabolism

Not fluent in English

iii Age Minimum

18

iv Age Maximum

34

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Crossover Design

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Crossover

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-11-12

21 Target Sample Size

25

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Postprandial Plasma Glucose

ii The metric or method of measurement used

Enzymatic-amperometric method (Biosen C-line, EKF Diagnostic, Germany)

iii The timepoint(s) of primary interest

30 minutes after each meal and hourly

Primary Outcome

i The Name of the outcome

Postprandial Insulin

ii The metric or method of measurement used

Enzyme-linked immunosorbent assay

iii The timepoint(s) of primary interest

30 minutes after each meal and hourly

24 Secondary Outcome

i The Name of the outcome

Postprandial Triglyceride

ii The metric or method of measurement used

Colourimetric method (RX Monza Randox, UK)

iii The timepoint(s) of primary interest

30 minutes after each meal and hourly

Secondary Outcome

i The Name of the outcome

Postprandial Non-esterified Fatty Acids

ii The metric or method of measurement used

Colourimetric method (RX Monza Randox, UK)

iii The timepoint(s) of primary interest

30 minutes after each meal and hourly

Secondary Outcome

i The Name of the outcome

Blood Pressure

ii The metric or method of measurement used

Using automatic electronic sphygmomanometer (Omron M7 intelli IT, Japan)

iii The timepoint(s) of primary interest

every 1 hour

Secondary Outcome

i The Name of the outcome

Heart Rate

ii The metric or method of measurement used

Using automatic electronic sphygmomanometer (Omron M7 intelli IT, Japan)

iii The timepoint(s) of primary interest

every 1 hour

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-12-18

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-17013259

28 Date of Registration in Primary Registry

2017-11-03

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Trial History Detail on 2017-11-22