Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03771690
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2018-12-07
Brief Title:
Individual Variability of Appetite Responses to a Standardised Meal
Sponsor:
Loughborough University
Organization:
Loughborough University
Study Overview
Official Title:
A Replicated Crossover Study to Explore Individual Variability of Appetite Responses to a Standardised Meal and Any Moderating Influence of the FTO Gene
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to examine the interindividual variability of subjective and hormonal appetite responses to a standardised meal in healthy men and explore any moderating influence of the fat mass and obesity associated gene FTO
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
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:
Meal ingestion initiates a series of co-ordinated subjective and hormonal appetite responses However it is not known whether interindividual variability in appetite exists in response to a standardised meal A recent approach proposed to quantify individual differences in the intervention response involves quantifying the participant-by-response interaction from replicated intervention and comparator arms Using this approach a replicated crossover study the current study will 1 investigate whether the perceived appetite and appetite-related hormone responses to a standardised meal are reproducible on repeated occasions 2 examine whether there is true individual variability in appetite responses to a standardised meal and 3 determine whether the fat mass and obesity associated gene FTO moderates the magnitude of appetite responses to a standardised meal
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 0900 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 1000 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 05 h 1030 and 1 h 1100 and appetite perceptions will be assessed at 1 h 1100
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
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 0900 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 1000 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 05 h 1030 and 1 h 1100 and appetite perceptions will be assessed at 1 h 1100
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None