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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03898206
Other study ID # 2019ISPAR003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 26, 2019
Est. completion date February 25, 2020

Study information

Verified date March 2019
Source University of Bedfordshire
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine whether breaking up prolonged sitting with short regular bouts of walking can reduce blood sugar and cholesterol levels after eating, which are risk markers for Type 2 diabetes and heart disease. This study will compare these responses in normal weight versus overweight/obese South Asian adults.


Description:

Participants will attend a preliminary testing session where height, weight, body fat and waist circumference will be measured. They will be familiarised with a motorised treadmill that will be used during the experimental visit below and will take part in an exercise test to determine a light-intensity walking speed for the experimental visit.

Participants will then attend two experimental visits in a random order:

1. Prolonged sitting: Participants will remain seated for 5 hours and instructed to reduce excessive movement.

2. Breaking up sitting with walking breaks: Participants will rise from the seated position every 30 minutes throughout the experimental period to walk on a motorised treadmill at a light intensity for 3 minutes. After performing walking activity, they will return to the seated position. In addition, blood sample will be taken at the resting position just before each physical activity bout. The activity breaks will be undertaken on 9 occasions, providing a total of 27 min of light intensity activity.

During each visit, blood pressure will be taken 11 times and blood samples will be taken 10 times. Participants will be given a breakfast and lunch meal to consume.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date February 25, 2020
Est. primary completion date October 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Self-identified South Asian ethnicity.

- Self-report sitting at least 7 hours per day.

- Normal weight, overweight or obese.

Exclusion Criteria:

- Unable to speak and read English.

- Contraindications to performing light-intensity walking.

- Diagnosed cardiovascular disease or diabetes.

Study Design


Intervention

Other:
Breaking up sitting with walking breaks
See Breaking up sitting with walking breaks arm description
Prolonged sitting
See Prolonged sitting arm description

Locations

Country Name City State
United Kingdom University of Bedfordshire Bedford Bedfordshire

Sponsors (1)

Lead Sponsor Collaborator
University of Bedfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial glucose Net incremental area under the curve for each 5 h condition will be calculated for glucose Measured over the 5 hour condition period
Secondary Postprandial triglycerides Net incremental area under the curve for each 5 h condition will be calculated for triglycerides Measured over the 5 hour condition period
Secondary Postprandial insulin Net incremental area under the curve for each 5 h condition will be calculated for insulin Measured over the 5 hour condition period
Secondary Blood pressure Mean systolic and diastolic blood pressure over the 5 h conditions Measured over the 5 hour condition period
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