Individual Variability of Appetite Responses to a Standardised Meal

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771690
• Other study ID #: R17-P178
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: December 2018
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Homozygous minor allele (AA) or major allele (TT) FTO rs9939609 genotype;

• Non-smoker;

• Weight stable for the previous 3 months.

Exclusion Criteria:

• Heterozygous FTO rs9939609 genotype (i.e., AT);

• 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.

Related Conditions & MeSH terms

• Appetitive Behavior
• Disease Susceptibility
• Genetic Predisposition to Disease
• Obesity

Intervention

Behavioral:
• Standardised meal
A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
Loughborough University	Teesside University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acylated ghrelin concentration	Control adjusted pre-to-post change in plasma acylated ghrelin concentration	1 hour (Plasma samples will be collected at 0 hour (pre) and 1 hour (post))
Secondary	Total peptide YY concentration	Control adjusted pre-to-post change in plasma total peptide YY concentration	1 hour (Plasma samples will be collected at 0 hour (pre) and 1 hour (post))
Secondary	Insulin concentration	Control adjusted pre-to-post change in plasma insulin concentration	0.5 hour (Plasma samples will be collected at 0 hour (pre) and 0.5 hour (post))
Secondary	Glucose concentration	Control adjusted pre-to-post change in plasma glucose concentration	0.5 hour (Plasma samples will be collected at 0 hour (pre) and 0.5 hour (post))
Secondary	Rating of perceived hunger	Control adjusted pre-to-post change in rating of perceived hunger. Perceived hunger will be measured using a 100 mm visual analogue scale anchored at 0, 'I am not hungry at all', and 100, 'I have never been more hungry'.	1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))
Secondary	Rating of perceived satisfaction	Control adjusted pre-to-post change in rating of perceived satisfaction. Perceived satisfaction will be measured using a 100 mm visual analogue scale anchored at 0, 'I am completely empty', and 100, 'I cannot eat another bite'.	1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))
Secondary	Rating of perceived fullness	Control adjusted pre-to-post change in rating of perceived fullness. Perceived fullness will be measured using a 100 mm visual analogue scale anchored at 0, 'Not full at all', and 100, 'Totally full'.	1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))
Secondary	Rating of perceived prospective food consumption	Control adjusted pre-to-post change in rating of perceived prospective food consumption. Perceived prospective food consumption will be measured using a 100 mm visual analogue scale anchored at 0, 'Nothing at all', and 100, 'A lot'.; consumption	1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))