Individual Variability of Appetite Responses to a Standardised Meal
NCT ID: NCT03771690
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2018-01-11
2018-05-01
Brief Summary
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Participants homozygous for the obesity risk A allele (AA) or low risk T allele (TT) of FTO rs9939609 will complete two fasted control and two standardised meal (5025 kJ energy, 47% carbohydrate, 9% protein, 44% fat) conditions in randomised sequences. Ratings of perceived appetite and venous blood samples will be taken before and after the interventions. Interindividual differences in appetite responses and the potential moderating influence of the FTO gene will be examined using bivariate correlations and linear mixed modelling.
Detailed Description
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A total of 18 healthy men will be recruited according to their FTO rs9939609 genotype: 9 homozygous minor allele (AA) and 9 homozygous major allele (TT). Participants will complete four main experimental conditions each separated by an interval of at least three days: two fasted control and two standardised meal conditions. Participants will arrive at the laboratory at 09:00 after a 13 h overnight fast and a cannula will be inserted into an antecubital vein for blood sampling. After 60 min rest, a fasting venous blood sample and rating of perceived appetite will be taken (0 h; 10:00). Participants will rest throughout all four conditions but will be provided with a standardised breakfast meal after the fasting measurements during the two meal conditions. Breakfast will be consumed within 15 min and consist of croissants, butter, chocolate spread, cereal biscuits and milkshake which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat). Subsequent venous blood samples will be taken at 0.5 h (10:30) and 1 h (11:00), and appetite perceptions will be assessed at 1 h (11:00).
Interindividual differences will be explored by correlating the two sets of response differences between meal and control conditions. Within-participant covariate-adjusted linear mixed models will be used to quantify participant-by-condition and FTO genotype-by-condition interactions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Control 1
After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00).
No interventions assigned to this group
Control 2
After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00).
No interventions assigned to this group
Standardised meal 1
After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00). A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).
Standardised meal
A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).
Standardised meal 2
After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00). A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).
Standardised meal
A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).
Interventions
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Standardised meal
A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).
Eligibility Criteria
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Inclusion Criteria
* Non-smoker;
* Weight stable for the previous 3 months.
Exclusion Criteria
* Any medical conditions (e.g., diabetes, coagulation or bleeding disorders);
* Taking any medication that might influence appetite, fat metabolism or blood glucose;
* Dieting or restrained eating behaviours;
* Any food allergies.
18 Years
50 Years
MALE
Yes
Sponsors
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Teesside University
OTHER
Loughborough University
OTHER
Responsible Party
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Fernanda Reistenbach Goltz
Principal Investigator
Principal Investigators
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David Stensel
Role: PRINCIPAL_INVESTIGATOR
Loughborough University
Fernanda Reistenbach Goltz
Role: PRINCIPAL_INVESTIGATOR
Loughborough University
Greg Atkinson
Role: PRINCIPAL_INVESTIGATOR
Teesside University
Locations
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Loughborough University
Loughborough, Leicestershire, United Kingdom
Countries
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References
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Goltz FR, Thackray AE, King JA, Dorling JL, Atkinson G, Stensel DJ. Interindividual Responses of Appetite to Acute Exercise: A Replicated Crossover Study. Med Sci Sports Exerc. 2018 Apr;50(4):758-768. doi: 10.1249/MSS.0000000000001504.
Atkinson G, Batterham AM. True and false interindividual differences in the physiological response to an intervention. Exp Physiol. 2015 Jun;100(6):577-88. doi: 10.1113/EP085070. Epub 2015 May 13.
Senn S, Rolfe K, Julious SA. Investigating variability in patient response to treatment--a case study from a replicate cross-over study. Stat Methods Med Res. 2011 Dec;20(6):657-66. doi: 10.1177/0962280210379174. Epub 2010 Aug 25.
Senn S. Mastering variation: variance components and personalised medicine. Stat Med. 2016 Mar 30;35(7):966-77. doi: 10.1002/sim.6739. Epub 2015 Sep 28.
Goltz FR, Thackray AE, Atkinson G, Lolli L, King JA, Dorling JL, Dowejko M, Mastana S, Stensel DJ. True Interindividual Variability Exists in Postprandial Appetite Responses in Healthy Men But Is Not Moderated by the FTO Genotype. J Nutr. 2019 Jul 1;149(7):1159-1169. doi: 10.1093/jn/nxz062.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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R17-P178
Identifier Type: -
Identifier Source: org_study_id