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Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men

Primary Purpose

Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • National Centre for Sport and Exercise Medicine, Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Exercise

No Intervention: Control

Arm Description

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

Participants will rest on day 1.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glucose changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
Blood pressure changes in response to exercise and/or feeding
Changes in blood pressure (systolic and diastolic).
Total cholesterol
Fasting plasma total cholesterol on day 1 and day 2 of both trials.
Insulin changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
High-density lipoprotein cholesterol
Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.
Low-density lipoprotein cholesterol
Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials.
Non-esterified fatty acids changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma non-esterified fatty acid concentrations in response to exercise and/or feeding on day 2.
Interleukin-6 changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.
C-Reactive protein changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.
Tumor Necrosis Factor concentrations
Fasting tumor necrosis factor on day 1 and 2 of both trials.
Peroxiredoxin-4 changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Superoxide dismutase 3
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials

Full Information

First Posted
May 13, 2019
Last Updated
January 27, 2020
Sponsor
Loughborough University
Collaborators
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT03952000
Brief Title
Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men
Official Title
Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
University Hospitals, Leicester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
South Asians have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role. It is important to understand the effect of exercise on endothelial function and coronary heart disease risk markers in the hope that exercise can be prescribed as an effective treatment to mitigate endothelial dysfunction and the risk of heart disease. Previous research from the investigators' laboratory has indicated that postprandial metabolism is impaired in South Asian men, but this, and other coronary heart disease risk markers, can be improved with acute exercise. However, the previous research was conducted in apparently healthy South Asian and White European men. The investigators now wish to quantify and compare the coronary heart disease risk marker and endothelial function response to acute exercise in centrally obese South Asian and White European individuals who are at a higher risk for diabetes and cardiovascular disease. On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. A HbA1c test will be performed to check participants are not diabetic. The modified Bruce Treadmill test will be performed to predict maximal oxygen uptake. On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume. On visits 3-6 participants will complete two, 2-day trials in a random, crossover design separated by at least 1 week. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed. On day 2, participants will arrive at 08:00 having fasted overnight for 10h (except plain water). A cannula will be inserted into the antecubital vein for collection of venous blood samples. Blood pressure will be measured at 08:00 (0h) and again at hourly intervals throughout the day. Endothelial function will measured at 08:15 (0.25h) and again at 3h. At 0h, a fasting blood sample will be collected. Subsequent venous blood samples will be collected at 1.5, 1.75, 2, 3, 4, 5, 5.5, 5.75, 6, 7, 8 and 9h. Participants will consume a standardised high fat breakfast at 1h and a standardised high fat lunch at 5h. The meals consist of 57% fat, 32% carbohydrate and 11% protein. The meals provide 14.3 kcal per kg of body mass. Participants will rest in the laboratory throughout day 2 of both the exercise and control trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction, Insulin Resistance, Oxidative Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Exercise
Arm Type
Experimental
Arm Description
Exercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1.
Arm Title
No Intervention: Control
Arm Type
No Intervention
Arm Description
Participants will rest on day 1.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
A 60 minute walk at 60% maximal oxygen uptake.
Primary Outcome Measure Information:
Title
Triacylglycerol changes in response to exercise and feeding
Description
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
Time Frame
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.
Title
Endothelial function changes in response to exercise and feeding
Description
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Time Frame
Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.
Secondary Outcome Measure Information:
Title
Glucose changes in response to exercise and/or feeding
Description
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
Time Frame
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.
Title
Blood pressure changes in response to exercise and/or feeding
Description
Changes in blood pressure (systolic and diastolic).
Time Frame
Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.
Title
Total cholesterol
Description
Fasting plasma total cholesterol on day 1 and day 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting.
Title
Insulin changes in response to exercise and/or feeding
Description
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
Time Frame
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.
Title
High-density lipoprotein cholesterol
Description
Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting.
Title
Low-density lipoprotein cholesterol
Description
Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting.
Title
Non-esterified fatty acids changes in response to exercise and/or feeding
Description
Fasting on day 1 and 2. Time-course of plasma non-esterified fatty acid concentrations in response to exercise and/or feeding on day 2.
Time Frame
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.
Title
Interleukin-6 changes in response to exercise and/or feeding
Description
Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.
Time Frame
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Title
C-Reactive protein changes in response to exercise and/or feeding
Description
Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.
Time Frame
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Title
Tumor Necrosis Factor concentrations
Description
Fasting tumor necrosis factor on day 1 and 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting.
Title
Peroxiredoxin-4 changes in response to exercise and/or feeding
Description
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Time Frame
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Title
Superoxide dismutase 3
Description
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials
Time Frame
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Stensel
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Centre for Sport and Exercise Medicine, Loughborough University
City
Loughborough
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will become available in 6 months after publication for 1 year.
IPD Sharing 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.
Citations:
PubMed Identifier
26438068
Citation
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.
Results Reference
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PubMed Identifier
23470315
Citation
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.
Results Reference
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Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men

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