Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03025347
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2017-01-17
Brief Title:
Effect of Exercise on Appetite Gut Peptides and Butyrylcholinesterase Activity in Variants of the FTO Gene
Sponsor:
Loughborough University
Organization:
Loughborough University
Study Overview
Official Title:
Effect of Exercise on Appetite Energy Intake Butyrylcholinesterase Activity and Gut Peptides in Men With Variants of the Obesity-linked FTO rs9939609 Polymorphism
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Using a database of individuals with FTO genetic data the study aims to assess the appetite energy intake butyrylcholinesterase gut hormone responses to a bout of moderate- to high intensity exercise in individuals with genetic variations in the FTO gene
Detailed Description:
The fat mass and obesity-associated gene FTO rs9939609 A allele is related to obesity greater food intake and impaired postprandial reduction of ghrelin Exercise acutely suppresses levels of ghrelin and appetite yet whether the response differs in people with or without the rs9939609 A allele is unknown This study assessed the effect of exercise on appetite appetite-regulatory hormones and energy intake in variants of the FTO rs9939609 polymorphism
Cohort
The investigators initially recruited 202 subjects to a database and measured FTO rs9939609 genotype From these subjects 12 individuals homozygous for the obesity-risk rs9939609 A allele and 12 homozygous for the T allele were recruited
A sample size of 24 was chosen based on previous data which suggested that a 34 pgml reduction in circulating acylated ghrelin during exercise could be detected with 80 power with a two-tailed t-test whilst assuming a standard deviation of differences of 54 pgml
Familiarisation trial
First participants will arrive for a familiarisation trial Participants will have been fasted for 2-3 hours beforehand Participants height weight and skinfold measures will be taken Furthermore a food preferences questionnaire will be completed to ensure the acceptability of food items provided during the study
Participants will complete a sub-maximal fitness test which will last for 16 minutes and will comprise of four four minute stages Initial treadmill speed will be set according to fitness and will be increased every four minutes by 05-15 kmh Prior to this test participants will be fitted with a cannula into an antecubital vein and a blood sample will be withdrawn after the test This will familiarise participants with the procedure and reduce any stress related to the novelty of the first visit
Next a maximal fitness test will be conducted to measure maximal oxygen uptake This will consist of an incremental protocol where the treadmill gradient will begin at 35 and will be increased by 25 every 3 minutes The speed of treadmill will remain constant and will be determined based on fitness levels Though the duration of the test is typically 9-15 minutes it will last until the participant reaches volitional exhaustion
After the fitness test and adequate recovery time participants will be presented with a buffet-style meal and instructed to eat until comfortably full and satisfied To finish participants will be given a calibrated set of weighing scales and instructions to standardize their food intake before each main trial
Main trials
Each participant will complete two main trials separated by 7 days an exercise trial and control trial In the 24 hours before a main trial participants will follow a set of standardization procedures Participants will record all foods consumed and the timings of meals before the first trial This will be subsequently replicated in the 24 hours prior to the second main trial Moreover participants will visit the lab to be provided with a meal and will be instructed to prepare and consume between 1900-2000 the night before each main trial Participants will also be instructed to refrain from strenuous physical activity and alcohol consumption during this period
Participants will report to the lab on the morning of each trial at 0800 following an overnight fast Participants will be instructed to walk slowly to the lab in the morning of each trial
At 0830 a cannula will be inserted into an antecubital vein followed by 60 minutes of rest On the exercise trial from 0930 to 1030 participants will run at a continuous pace that corresponds to 70 of the participants maximal oxygen uptake Participants will rest on the bed during this same period of the control trial Participants will rest and will be provided with a selection of movies to watch for the rest of the trial
There will be two meals provided to the participants a standardised meal and an ad libitum buffet style meal The standardised meal will be a fixed breakfast meal that participants will be provided at 1050 and will be instructed to consume within 20 minutes The ad libitum buffet style meal will be given at 1550 and will consist of an array of foods with differing energy and macronutrient compositions Participants will be presented with the buffet foods for 30 minutes and will be instructed to eat until comfortably full and satisfied
Statistical procedures
Linear mixed model with factors being trial exercise or control genotype AA or TT and time will be performed on all time-course measures Area under the curve will be calculated using the trapezoidal rule for outcome measures taken periodically throughout the day Linear mixed models will also be used for trial and genotype comparisons of area under the curve values and measures not taken throughout the day At points of interest where significant main and interaction effects occur post-hoc analysis was conducted using Holm-Bonferroni adjusted t-tests Statistical significance was accepted as P 005
Cohort
The investigators initially recruited 202 subjects to a database and measured FTO rs9939609 genotype From these subjects 12 individuals homozygous for the obesity-risk rs9939609 A allele and 12 homozygous for the T allele were recruited
A sample size of 24 was chosen based on previous data which suggested that a 34 pgml reduction in circulating acylated ghrelin during exercise could be detected with 80 power with a two-tailed t-test whilst assuming a standard deviation of differences of 54 pgml
Familiarisation trial
First participants will arrive for a familiarisation trial Participants will have been fasted for 2-3 hours beforehand Participants height weight and skinfold measures will be taken Furthermore a food preferences questionnaire will be completed to ensure the acceptability of food items provided during the study
Participants will complete a sub-maximal fitness test which will last for 16 minutes and will comprise of four four minute stages Initial treadmill speed will be set according to fitness and will be increased every four minutes by 05-15 kmh Prior to this test participants will be fitted with a cannula into an antecubital vein and a blood sample will be withdrawn after the test This will familiarise participants with the procedure and reduce any stress related to the novelty of the first visit
Next a maximal fitness test will be conducted to measure maximal oxygen uptake This will consist of an incremental protocol where the treadmill gradient will begin at 35 and will be increased by 25 every 3 minutes The speed of treadmill will remain constant and will be determined based on fitness levels Though the duration of the test is typically 9-15 minutes it will last until the participant reaches volitional exhaustion
After the fitness test and adequate recovery time participants will be presented with a buffet-style meal and instructed to eat until comfortably full and satisfied To finish participants will be given a calibrated set of weighing scales and instructions to standardize their food intake before each main trial
Main trials
Each participant will complete two main trials separated by 7 days an exercise trial and control trial In the 24 hours before a main trial participants will follow a set of standardization procedures Participants will record all foods consumed and the timings of meals before the first trial This will be subsequently replicated in the 24 hours prior to the second main trial Moreover participants will visit the lab to be provided with a meal and will be instructed to prepare and consume between 1900-2000 the night before each main trial Participants will also be instructed to refrain from strenuous physical activity and alcohol consumption during this period
Participants will report to the lab on the morning of each trial at 0800 following an overnight fast Participants will be instructed to walk slowly to the lab in the morning of each trial
At 0830 a cannula will be inserted into an antecubital vein followed by 60 minutes of rest On the exercise trial from 0930 to 1030 participants will run at a continuous pace that corresponds to 70 of the participants maximal oxygen uptake Participants will rest on the bed during this same period of the control trial Participants will rest and will be provided with a selection of movies to watch for the rest of the trial
There will be two meals provided to the participants a standardised meal and an ad libitum buffet style meal The standardised meal will be a fixed breakfast meal that participants will be provided at 1050 and will be instructed to consume within 20 minutes The ad libitum buffet style meal will be given at 1550 and will consist of an array of foods with differing energy and macronutrient compositions Participants will be presented with the buffet foods for 30 minutes and will be instructed to eat until comfortably full and satisfied
Statistical procedures
Linear mixed model with factors being trial exercise or control genotype AA or TT and time will be performed on all time-course measures Area under the curve will be calculated using the trapezoidal rule for outcome measures taken periodically throughout the day Linear mixed models will also be used for trial and genotype comparisons of area under the curve values and measures not taken throughout the day At points of interest where significant main and interaction effects occur post-hoc analysis was conducted using Holm-Bonferroni adjusted t-tests Statistical significance was accepted as P 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None