Brief Summary

The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in healthy South Asian and White European women. Participants will complete two, 2-day trials in a random, crossover design separated by at least 3 weeks to control for the menstrual cycle phase. On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour. It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline

Completed

Started Oct 2017

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

October 1, 2017

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed

Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

October 17, 2018

Last Update Submit

May 13, 2019

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Endothelial Dysfunction Insulin Resistance Oxidative Stress

Outcome Measures

Primary Outcomes (1)

Triacylglycerol
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h.

Secondary Outcomes (12)

Endothelial function
Day 1 fasting and 8.75h. Day 2 fasting and 3.5h.
Blood pressure
Day 1 fasting. Day 2 fasting and 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h and 9h.
Glucose
Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h
Total cholesterol
Day 1 fasting. Day 2 fasting.
Insulin
Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h, 8h.
+7 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1. Participants will return the following day and consume a high fat breakfast and lunch.

Behavioral: Exercise

Control

NO INTERVENTION

Participants will rest on day 1. Participants will return the following day where they will consume a high fat breakfast and lunch.

Interventions

ExerciseBEHAVIORAL

A 60 minute walk at 60% maximal oxygen uptake.

Exercise

Eligibility Criteria

Age18 Years - 40 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

to 40 year old South Asian and White European women;
Be able to walk continuously for 1 hour;
Weight stable for the past 3 months;
Non-smokers;
No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).

You may not qualify if:

Musculoskeletal injury that has affected normal ambulation within the last month;
Congenital heart disease;
Any muscle or bone injuries that do not allow them to walk on a treadmill;
Uncontrolled exercise-induced asthma;
Coagulation or bleeding disorders;
Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
Taking any medication that might influence fat metabolism;
Taking any medication that might influence blood glucose (e.g., insulin for diabetes);
Heart conditions;
Smoking;
Dieting or restrained eating behaviours;
Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
A food allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Loughborough Universitylead
University Hospitals, Leicestercollaborator

Study Sites (1)

National Centre for Sport and Exercise Medicine, Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Related Publications (3)

Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
PMID: 26438068BACKGROUND
Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
PMID: 23470315BACKGROUND
Roberts MJ, Thackray AE, Wadley AJ, Alotaibi TF, Hunter DJ, Thompson J, Fujihira K, Miyashita M, Mastana S, Bishop NC, O'Donnell E, Davies MJ, King JA, Yates T, Webb D, Stensel DJ. Effect of Acute Walking on Endothelial Function and Postprandial Lipemia in South Asians and White Europeans. Med Sci Sports Exerc. 2023 May 1;55(5):794-802. doi: 10.1249/MSS.0000000000003098. Epub 2022 Dec 5.
PMID: 36729923DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesInsulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

Matthew Roberts
Loughborough University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

October 1, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

May 14, 2019

Record last verified: 2019-05

Locations

GB(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Exercise

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations