NCT03025347

Brief Summary

Using a database of individuals with FTO genetic data, the study aims to assess the appetite, energy intake, butyrylcholinesterase, gut hormone responses to a bout of moderate- to high intensity exercise in individuals with genetic variations in the FTO gene.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

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

December 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

January 17, 2017

Last Update Submit

February 5, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • Plasma acylated ghrelin concentrations (N=24)

    Measured using ELISA from venous blood samples

    24 hours

  • Plasma desacyl ghrelin concentrations (N=24)

    Measured using ELISA from venous blood samples

    24 hours

  • Subjective appetite (N=24)

    Measured using visual analogue scales

    24 hours

  • Ad-libitum energy intake (N=24)

    Measured at laboratory-based meals

    24 hours

  • Plasma butyrylcholinesterase activity (N=24)

    Measured using Ellman's reagent protocol

    First hour of main trial (three samples).

Secondary Outcomes (3)

  • Plasma total glucagon-like peptide 1 concentrations (N=24)

    24 hours

  • Plasma total peptide yy concentrations (N=24)

    24 hours

  • Plasma leptin concentrations (N=24)

    Baseline (fasting) sample

Study Arms (2)

Control

EXPERIMENTAL

Experimental day where participants rest.

Other: Control

Exercise

EXPERIMENTAL

Experimental day where participants complete a run.

Other: Exercise

Interventions

ControlOTHER

Participants complete a resting control condition instead of a run.

Control

Participants complete a 60 minute run at 70% of their maximal oxygen uptake

Exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-smoker, not currently dieting, weight stable for \>3 months (self-reported), no personal history of cardiovascular disease, metabolic disease or dyslipidaemia, European ancestry, no psychiatric or medical condition

You may not qualify if:

  • food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Related Publications (4)

  • Frayling TM, Timpson NJ, Weedon MN, Zeggini E, Freathy RM, Lindgren CM, Perry JR, Elliott KS, Lango H, Rayner NW, Shields B, Harries LW, Barrett JC, Ellard S, Groves CJ, Knight B, Patch AM, Ness AR, Ebrahim S, Lawlor DA, Ring SM, Ben-Shlomo Y, Jarvelin MR, Sovio U, Bennett AJ, Melzer D, Ferrucci L, Loos RJ, Barroso I, Wareham NJ, Karpe F, Owen KR, Cardon LR, Walker M, Hitman GA, Palmer CN, Doney AS, Morris AD, Smith GD, Hattersley AT, McCarthy MI. A common variant in the FTO gene is associated with body mass index and predisposes to childhood and adult obesity. Science. 2007 May 11;316(5826):889-94. doi: 10.1126/science.1141634. Epub 2007 Apr 12.

    PMID: 17434869BACKGROUND
  • Speakman JR, Rance KA, Johnstone AM. Polymorphisms of the FTO gene are associated with variation in energy intake, but not energy expenditure. Obesity (Silver Spring). 2008 Aug;16(8):1961-5. doi: 10.1038/oby.2008.318. Epub 2008 Jun 12.

    PMID: 18551109BACKGROUND
  • Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15.

    PMID: 23867619BACKGROUND
  • Dorling JL, Clayton DJ, Jones J, Carter WG, Thackray AE, King JA, Pucci A, Batterham RL, Stensel DJ. A randomized crossover trial assessing the effects of acute exercise on appetite, circulating ghrelin concentrations, and butyrylcholinesterase activity in normal-weight males with variants of the obesity-linked FTO rs9939609 polymorphism. Am J Clin Nutr. 2019 Nov 1;110(5):1055-1066. doi: 10.1093/ajcn/nqz188.

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David J Stensel, PhD

    Loughborough University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Exercise Metabolism

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 19, 2017

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations