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出境医 / 临床实验 / Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men

Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Cardiovascular Diseases Endothelial Dysfunction Insulin Resistance Oxidative Stress Behavioral: Exercise Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental: Exercise
Exercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1.
Behavioral: Exercise
A 60 minute walk at 60% maximal oxygen uptake.

No Intervention: No Intervention: Control
Participants will rest on day 1.
Outcome Measures
Primary Outcome Measures :
  1. Triacylglycerol changes in response to exercise and feeding [ 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. ]
    Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.

  2. Endothelial function changes in response to exercise and feeding [ Time Frame: Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours. ]
    Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.


Secondary Outcome Measures :
  1. Glucose changes in response to exercise and/or feeding [ 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. ]
    Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.

  2. Blood pressure changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours. ]
    Changes in blood pressure (systolic and diastolic).

  3. Total cholesterol [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    Fasting plasma total cholesterol on day 1 and day 2 of both trials.

  4. Insulin changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours. ]
    Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.

  5. High-density lipoprotein cholesterol [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.

  6. Low-density lipoprotein cholesterol [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials.

  7. Non-esterified fatty acids changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours. ]
    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.

  8. Interleukin-6 changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.

  9. C-Reactive protein changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.

  10. Tumor Necrosis Factor concentrations [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    Fasting tumor necrosis factor on day 1 and 2 of both trials.

  11. Peroxiredoxin-4 changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.

  12. Superoxide dismutase 3 [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
Layout table for location information
United Kingdom
National Centre for Sport and Exercise Medicine, Loughborough University
Loughborough, United Kingdom, LE11 3TU
Sponsors and Collaborators
Loughborough University
University Hospitals, Leicester
Investigators
Layout table for investigator information
Principal Investigator: David Stensel Loughborough University
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE January 3, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • Triacylglycerol changes in response to exercise and feeding [ 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. ]
    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 [ Time Frame: Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours. ]
    Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Triacylglycerol changes in response to exercise and feeding [ 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. ]
    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 [ Time Frame: Day 1 fasting and 8.75hours. Day 2 fasting and 3.5hours. ]
    Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Glucose changes in response to exercise and/or feeding [ 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. ]
    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 [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours. ]
    Changes in blood pressure (systolic and diastolic).
  • Total cholesterol [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    Fasting plasma total cholesterol on day 1 and day 2 of both trials.
  • Insulin changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours. ]
    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 [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.
  • Low-density lipoprotein cholesterol [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    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 [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours. ]
    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 [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    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 [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    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 [ Time Frame: Day 1 fasting. Day 2 fasting. ]
    Fasting tumor necrosis factor on day 1 and 2 of both trials.
  • Peroxiredoxin-4 changes in response to exercise and/or feeding [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
  • Superoxide dismutase 3 [ Time Frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours. ]
    Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men
Official Title  ICMJE Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
  • Endothelial Dysfunction
  • Insulin Resistance
  • Oxidative Stress
Intervention  ICMJE Behavioral: Exercise
A 60 minute walk at 60% maximal oxygen uptake.
Study Arms  ICMJE
  • Experimental: Experimental: Exercise
    Exercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1.
    Intervention: Behavioral: Exercise
  • No Intervention: No Intervention: Control
    Participants will rest on day 1.
Publications *
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
24
Actual Study Completion Date  ICMJE September 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952000
Other Study ID Numbers  ICMJE R18-P120
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (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.
Responsible Party Matthew Roberts, Loughborough University
Study Sponsor  ICMJE Loughborough University
Collaborators  ICMJE University Hospitals, Leicester
Investigators  ICMJE
Principal Investigator: David Stensel Loughborough University
PRS Account Loughborough University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP