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Individual Variability of Appetite Responses to a Standardised Meal

Primary Purpose

Appetitive Behavior, Obesity, Genetic Predisposition to Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Standardised meal
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Appetitive Behavior focused on measuring Appetite, FTO, Ghrelin, Individual variability, Meal intake, Peptide YY

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Arm Label

Control 1

Control 2

Standardised meal 1

Standardised meal 2

Arm Description

After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00).

After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00).

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).

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).

Outcomes

Primary Outcome Measures

Acylated ghrelin concentration
Control adjusted pre-to-post change in plasma acylated ghrelin concentration

Secondary Outcome Measures

Total peptide YY concentration
Control adjusted pre-to-post change in plasma total peptide YY concentration
Insulin concentration
Control adjusted pre-to-post change in plasma insulin concentration
Glucose concentration
Control adjusted pre-to-post change in plasma glucose concentration
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'.
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'.
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'.
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

Full Information

First Posted
December 7, 2018
Last Updated
December 8, 2018
Sponsor
Loughborough University
Collaborators
Teesside University
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1. Study Identification

Unique Protocol Identification Number
NCT03771690
Brief Title
Individual Variability of Appetite Responses to a Standardised Meal
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
Teesside University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetitive Behavior, Obesity, Genetic Predisposition to Disease
Keywords
Appetite, FTO, Ghrelin, Individual variability, Meal intake, Peptide YY

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control 1
Arm Type
No Intervention
Arm Description
After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00).
Arm Title
Control 2
Arm Type
No Intervention
Arm Description
After a 13 h overnight fast, participants will rest in the laboratory for the duration of the trial (09:00-11:00).
Arm Title
Standardised meal 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Standardised meal 2
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standardised meal
Intervention Description
A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).
Primary Outcome Measure Information:
Title
Acylated ghrelin concentration
Description
Control adjusted pre-to-post change in plasma acylated ghrelin concentration
Time Frame
1 hour (Plasma samples will be collected at 0 hour (pre) and 1 hour (post))
Secondary Outcome Measure Information:
Title
Total peptide YY concentration
Description
Control adjusted pre-to-post change in plasma total peptide YY concentration
Time Frame
1 hour (Plasma samples will be collected at 0 hour (pre) and 1 hour (post))
Title
Insulin concentration
Description
Control adjusted pre-to-post change in plasma insulin concentration
Time Frame
0.5 hour (Plasma samples will be collected at 0 hour (pre) and 0.5 hour (post))
Title
Glucose concentration
Description
Control adjusted pre-to-post change in plasma glucose concentration
Time Frame
0.5 hour (Plasma samples will be collected at 0 hour (pre) and 0.5 hour (post))
Title
Rating of perceived hunger
Description
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'.
Time Frame
1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))
Title
Rating of perceived satisfaction
Description
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'.
Time Frame
1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))
Title
Rating of perceived fullness
Description
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'.
Time Frame
1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))
Title
Rating of perceived prospective food consumption
Description
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
Time Frame
1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Stensel
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernanda Reistenbach Goltz
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Greg Atkinson
Organizational Affiliation
Teesside University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29240652
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.
Results Reference
background
PubMed Identifier
25823596
Citation
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.
Results Reference
background
PubMed Identifier
20739334
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.
Results Reference
background
PubMed Identifier
26415869
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.
Results Reference
background
PubMed Identifier
31132105
Citation
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.
Results Reference
derived

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Individual Variability of Appetite Responses to a Standardised Meal

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