NCT03698786

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 24, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

September 27, 2018

Last Update Submit

March 12, 2019

Conditions

Risk Factor, CardiovascularPhysical ActivityPre-diabetes

Outcome Measures

Primary Outcomes (1)

  • Plasma Acylated ghrelin concentration

    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 Outcomes (7)

  • Plasma TAG concentration

    2 days

  • Plasma triacylglycerol (TAG) concentration

    2 days

  • Plasma high-density lipoprotein (HDL) cholesterol concentration

    2 days

  • Cardiorespiratory fitness

    2 days

  • Plasma Glucose concentration for impaired glucose tolerance (IGT)

    2 days

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: Exercise

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.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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.

European malesSouth Asian males

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied & Human Sciences Human Performance Lab

Kingston upon Thames, Surrey, KT1 2EE, United Kingdom

Location

Related Publications (8)

  • Gijsberts CM, den Ruijter HM, Asselbergs FW, Chan MY, de Kleijn DP, Hoefer IE. Biomarkers of Coronary Artery Disease Differ Between Asians and Caucasians in the General Population. Glob Heart. 2015 Dec;10(4):301-311.e11. doi: 10.1016/j.gheart.2014.11.004. Epub 2015 Mar 7.

    PMID: 26014657BACKGROUND

  • Gujral UP, Pradeepa R, Weber MB, Narayan KM, Mohan V. Type 2 diabetes in South Asians: similarities and differences with white Caucasian and other populations. Ann N Y Acad Sci. 2013 Apr;1281(1):51-63. doi: 10.1111/j.1749-6632.2012.06838.x. Epub 2013 Jan 14.

    PMID: 23317344BACKGROUND

  • Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953.

    PMID: 27881363BACKGROUND

  • Wulan SN, Westerterp KR, Plasqui G. Metabolic profile before and after short-term overfeeding with a high-fat diet: a comparison between South Asian and White men. Br J Nutr. 2014 May 28;111(10):1853-61. doi: 10.1017/S0007114514000014. Epub 2014 Feb 10.

    PMID: 24506887BACKGROUND

  • Bailey DP, Smith LR, Chrismas BC, Taylor L, Stensel DJ, Deighton K, Douglas JA, Kerr CJ. Appetite and gut hormone responses to moderate-intensity continuous exercise versus high-intensity interval exercise, in normoxic and hypoxic conditions. Appetite. 2015 Jun;89:237-45. doi: 10.1016/j.appet.2015.02.019. Epub 2015 Feb 17.

    PMID: 25700630BACKGROUND

  • Deighton K, Barry R, Connon CE, Stensel DJ. Appetite, gut hormone and energy intake responses to low volume sprint interval and traditional endurance exercise. Eur J Appl Physiol. 2013 May;113(5):1147-56. doi: 10.1007/s00421-012-2535-1. Epub 2012 Oct 31.

    PMID: 23111564BACKGROUND

  • Gholap N, Davies M, Patel K, Sattar N, Khunti K. Type 2 diabetes and cardiovascular disease in South Asians. Prim Care Diabetes. 2011 Apr;5(1):45-56. doi: 10.1016/j.pcd.2010.08.002. Epub 2010 Sep 25.

    PMID: 20869934BACKGROUND

  • King JA, Garnham JO, Jackson AP, Kelly BM, Xenophontos S, Nimmo MA. Appetite-regulatory hormone responses on the day following a prolonged bout of moderate-intensity exercise. Physiol Behav. 2015 Mar 15;141:23-31. doi: 10.1016/j.physbeh.2014.12.050. Epub 2015 Jan 3.

    PMID: 25562575BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum stored according to Human Tissue Act for maximum of 6 years

MeSH Terms

Conditions

Motor ActivityGlucose Intolerance

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Juliet Juliet

    Kingston University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Health & Exercise Prescription

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 9, 2018

Study Start

May 24, 2017

Primary Completion

December 23, 2018

Study Completion

March 1, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)