Individual Variability of Appetite Responses to a Standardised Meal

NCT03771690 | Completed

• 1 other identifier: R17-P178
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetitive Behavior; Obesity; Genetic Predisposition to Disease

Keywords

Appetite; FTO; Ghrelin; Individual variability; Meal intake; Peptide YY

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Total peptide YY concentration

  1 hour (Plasma samples will be collected at 0 hour (pre) and 1 hour (post))

• Insulin concentration

  0.5 hour (Plasma samples will be collected at 0 hour (pre) and 0.5 hour (post))

• Glucose concentration

  0.5 hour (Plasma samples will be collected at 0 hour (pre) and 0.5 hour (post))

• Rating of perceived hunger

  1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))

• Rating of perceived satisfaction

  1 hour (Visual analogue scales will be completed at 0 hour (pre) and 1 hour (post))

Study Arms (4)

Control 1

NO INTERVENTION

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

Control 2

NO INTERVENTION

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

Standardised meal 1

EXPERIMENTAL

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).

Behavioral: Standardised meal

Standardised meal 2

EXPERIMENTAL

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).

Behavioral: Standardised meal

Interventions

Standardised meal BEHAVIORAL

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

Standardised meal 1; Standardised meal 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Homozygous minor allele (AA) or major allele (TT) FTO rs9939609 genotype;
• Non-smoker;
• Weight stable for the previous 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loughborough University: lead
• Teesside University: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 29240652 BACKGROUND

• 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.

  PMID: 25823596 BACKGROUND

• 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.

  PMID: 20739334 BACKGROUND

• 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.

  PMID: 26415869 BACKGROUND

• 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.

  PMID: 31132105 DERIVED

MeSH Terms

Conditions

Appetitive Behavior; Obesity; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes; Pathologic Processes

Study Officials

• David Stensel

  Loughborough University

  PRINCIPAL INVESTIGATOR

• Fernanda Reistenbach Goltz

  Loughborough University

  PRINCIPAL INVESTIGATOR

• Greg Atkinson

  Teesside 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: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: January 11, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)