Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors

March 12, 2019 updated by: Hannah Moir, Kingston University

Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors in South Asian and White European Men

The aim of this study is to examine the effect of a single bout of moderate exercise, standardized breakfast and buffet meal on appetite-related hormones, type two diabetes and cardiovascular risk factors with a comparison between healthy South Asian and white European men. It is of interest to see if any factor differences occur in appetite-regulating hormones and cardiovascular disease risk factors whilst exercising. If so strategies may be used to alter regulation in diet and exercise to reduce risk cardiovascular disease as this is the number one cause of death globally.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Cardiovascular diseases are recognised as the number one cause of death globally. Furthermore, diabetes is a major risk factor for cardiovascular disorders with abundant evidence showing that patients with type 2 diabetes (T2D) are at higher risk of cardiovascular disease (CVD) than those with a normal glycaemia.

In contrast to the declining numbers in the Western world, the prevalence of CVD and T2D is growing in low - and middle - income countries accompanied by a rapid increase of mortality and morbidity. Of interest, a rise in CVD prevalence has been particularly observed in people of South Asian origin including India, Bangladesh, Pakistan, Sri Lanka or Nepal with a projection showing that in this population deaths attributed to CVD will rise globally to nearly 36 % in 2030 compared to 29 % in 2005. South Asians collectively form 20% of the global population while in the UK they are the largest ethnic minority group representing over 5% of the total UK population .

Although the majority of research has been conducted mainly on White individuals, recent studies have revealed that traditional CVD risk factors such as hypertension, dyslipidaemia, insulin resistance and diabetes are higher in South Asians than other ethnicities. The factors underlying the high CVD risk in this population remain largely unexplained even though genetic predisposition and physical inactivity could play a key role. In contrast to European counterparts, sedentary lifestyles or physical inactivity have been identified as an important coronary heart disease (CHD) risk factor in South Asians. A systematic review from the United Kingdom (U.K.) showed that South Asians are participating in up to 50-75% less physical activity compared to their European counterparts.

In addition to the traditional risk factors there are emerging biomarkers which could represent meaningful predictors of metabolic disorders and related complications. Specifically, appetite hormones secreted mainly by the gastrointestinal tract, such as Acylated Ghrelin or Peptide YY (PYY) have shown potential effects on glucose homeostasis and cardiovascular system. Current experimental studies suggest beneficial cardiovascular, anti-inflammatory and anti-apoptotic effects of ghrelin in the cardiovascular system.

Although evidence suggests that ghrelin may be a potential metabolic risk factor and is important in appetite regulation, no studies to the researcher's knowledge have examined changes of this peptide in South Asians despite the fact that CVD and T2D burden in the South Asian population is growing. Likewise, although studies have investigated the effects of exercise on ghrelin and other appetite hormones, no study has taken in consideration the effects of exercise on appetite gut hormones in South Asian populations.

Therefore, this research project aims to examine specific appetite hormones in response to a single bout of exercise, standardised meal and ad libitum buffet meal, with a comparison between South Asians and White Europeans identifying potential relationships with genetic and other metabolic risk factors.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Surrey
      • Kingston Upon Thames, Surrey, United Kingdom, KT1 2EE
        • Applied & Human Sciences Human Performance Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

This study will involve a cohort of 15 White European and 15 South Asian (India, Pakistan, Sri Lanka, Nepal, Bangladesh, Maldives and Bhutan), men, between the ages of 18-50 years with no known underlying disease.

Description

Inclusion Criteria:

  • Non-smoker
  • Non-dieting
  • Physically well to participant in maximal exercise
  • Male
  • Not taking any anticoagulant or anti-inflammatory medication
  • Between the ages 18-50
  • White European or South Asian

Exclusion Criteria:

  • Those that are taking any anticoagulant or anti-inflammatory medication
  • Those with a known medical condition such as diabetes, cardiovascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
European males

This study will involve a cohort of 15 White European men, between the ages of 18-50 years. Participants will be non-smokers, not dieting, and physically well to participate.

Participants will be required to exercise on one occasion.

Participants will be required to complete two, 8-hours trials (exercise & control) in a randomised order, preceded by 2 hours of preliminary testing (baseline) with no more than 14 days between conditions.
South Asian males

This study will involve a cohort of 15 South Asian (India, Pakistan, Sri Lanka, Nepal, Bangladesh, Maldives and Bhutan), men, between the ages of 18-50 years. Participants will be non-smokers, not dieting, and physically well to participate.

Participants will be required to exercise on one occasion.

Participants will be required to complete two, 8-hours trials (exercise & control) in a randomised order, preceded by 2 hours of preliminary testing (baseline) with no more than 14 days between conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Acylated ghrelin concentration
Time Frame: 2 days
Plasma acylated ghrelin will be examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Bertin Bioreagent, Montigny le Bretonneux, France) will be used to measure plasma acylated ghrelin concentration. The sample will be collected from whole blood using venepuncture.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma TAG concentration
Time Frame: 2 days
Plasma Insulin will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Mercodia, Uppsala, Sweden) will be used to measure plasma Insulin concentration. The sample will be collected from whole blood using venepuncture.
2 days
Plasma triacylglycerol (TAG) concentration
Time Frame: 2 days
Plasma TAG concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.
2 days
Plasma high-density lipoprotein (HDL) cholesterol concentration
Time Frame: 2 days
Plasma HDL concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.
2 days
Cardiorespiratory fitness
Time Frame: 2 days
Cardiorespiratory fitness will be determined during the preliminary test (please refer to study design for details) using an incremental exercise test to volitional exhaustion on an electromagnetically braked cycle ergometer (Lode Excalibur Sport, Groningen, Netherlands). Participants will cycle at a self-selected pedal rate between 70 to 90 revolutions per minute for 3 min at 80 watts (warm up), followed by increments of 30 watts every 3 minutes until volitional fatigue. The sample will be collected from whole blood using venepuncture.
2 days
Plasma Glucose concentration for impaired glucose tolerance (IGT)
Time Frame: 2 days
Plasma glucose concentration will be determined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details) by enzymatic, colorimetric methods using a bench top analyser (Pentra 400; HORIBA ABX Diagnostics, Montpellier, France). The sample will be collected from whole blood using venepuncture.
2 days
Plasma Peptide YY concentration
Time Frame: 2 days
Plasma PYY will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Millipore, Billerica, USA) will be used to measure plasma PYY concentration. The sample will be collected from whole blood using venepuncture.
2 days
Plasma Leptin concentration
Time Frame: 2 days
Plasma leptin will be also examined before and after the standardised breakfast, libitum buffet meal and exercise and before leaving the laboratory (please refer to study design for details). Commercially available enzyme-linked immunosorbent assays (Millipore, Billerica, USA) will be used to measure plasma leptin concentration. The sample will be collected from whole blood using venepuncture.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Juliet Juliet, Kingston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Actual)

December 23, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • KingstonUSport2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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