NCT03952000

Brief Summary

The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in centrally obese South Asian and White European men. Participants will complete two, 2-day trials in a random, crossover design separated by at least a week. 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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

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

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

Study Start

First participant enrolled

January 3, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

May 13, 2019

Last Update Submit

January 27, 2020

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesEndothelial DysfunctionInsulin ResistanceOxidative Stress

Outcome Measures

Primary Outcomes (2)

  • Triacylglycerol changes in response to exercise and feeding

    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 (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.

  • Endothelial function changes in response to exercise and feeding

    Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.

    Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.

Secondary Outcomes (12)

  • Glucose changes in response to exercise and/or feeding

    Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.

  • Blood pressure changes in response to exercise and/or feeding

    Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.

  • Total cholesterol

    Day 1 fasting. Day 2 fasting.

  • Insulin changes in response to exercise and/or feeding

    Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.

  • High-density lipoprotein cholesterol

    Day 1 fasting. Day 2 fasting.

  • +7 more secondary outcomes

Study Arms (2)

Experimental: Exercise

EXPERIMENTAL

Exercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1.

Behavioral: Exercise

No Intervention: Control

NO INTERVENTION

Participants will rest on day 1.

Interventions

ExerciseBEHAVIORAL

A 60 minute walk at 60% maximal oxygen uptake.

Experimental: Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 60 year old South Asian and White European men;
  • Centrally obese (waist circumference \>90cm for South Asians, \>94cm for White Europeans);
  • Weight stable for the past 3 months;
  • Non-smokers;
  • No known contradictions to maximal exertion exercise.

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

Study Sites (1)

National Centre for Sport and Exercise Medicine, Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Related Publications (2)

  • 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

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

  • David Stensel

    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

May 13, 2019

First Posted

May 16, 2019

Study Start

January 3, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request. Study protocol, statistical analysis plan and informed consent forms are also available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will become available in 6 months after publication for 1 year.
Access Criteria
Data will be available to other researchers who would like to run the same statistical methods we have used to check the interpretation of results.

Locations

GB(1)