Effect of Exercise on Appetite, Gut Peptides and Butyrylcholinesterase Activity in Variants of the FTO Gene

February 5, 2019 updated by: Professor David Stensel, Loughborough University

Effect of Exercise on Appetite, Energy Intake, Butyrylcholinesterase Activity and Gut Peptides in Men With Variants of the Obesity-linked FTO rs9939609 Polymorphism

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 pg/ml 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 pg/ml.

Familiarisation trial

First, participants will arrive for a familiarisation trial. Participants will have been fasted for ~2-3 hours beforehand. Participant's 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 0.5-1.5 km/h. 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 3.5% and will be increased by 2.5% 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 19:00-20:00 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 08:00 following an overnight fast. Participants will be instructed to walk slowly to the lab in the morning of each trial.

At 08:30, a cannula will be inserted into an antecubital vein followed by 60 minutes of rest. On the exercise trial, from 09:30 to 10:30, participants will run at a continuous pace that corresponds to 70% of the participant's 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 10:50, and will be instructed to consume within 20 minutes. The ad libitum buffet style meal will be given at 15:50 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 < 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Loughborough, United Kingdom, LE11 3TU
        • Loughborough University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • non-smoker, not currently dieting, weight stable for >3 months (self-reported), no personal history of cardiovascular disease, metabolic disease or dyslipidaemia, European ancestry, no psychiatric or medical condition

Exclusion Criteria:

  • food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Control
Experimental day where participants rest.
Other: Control
Participants complete a resting control condition instead of a run.
EXPERIMENTAL: Exercise
Experimental day where participants complete a run.
Other: Exercise
Participants complete a 60 minute run at 70% of their maximal oxygen uptake

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma acylated ghrelin concentrations (N=24)
Time Frame: 24 hours
Measured using ELISA from venous blood samples
24 hours
Plasma desacyl ghrelin concentrations (N=24)
Time Frame: 24 hours
Measured using ELISA from venous blood samples
24 hours
Subjective appetite (N=24)
Time Frame: 24 hours
Measured using visual analogue scales
24 hours
Ad-libitum energy intake (N=24)
Time Frame: 24 hours
Measured at laboratory-based meals
24 hours
Plasma butyrylcholinesterase activity (N=24)
Time Frame: First hour of main trial (three samples).
Measured using Ellman's reagent protocol
First hour of main trial (three samples).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma total glucagon-like peptide 1 concentrations (N=24)
Time Frame: 24 hours
Measured using ELISA from venous blood samples
24 hours
Plasma total peptide yy concentrations (N=24)
Time Frame: 24 hours
Measured using ELISA from venous blood samples
24 hours
Plasma leptin concentrations (N=24)
Time Frame: Baseline (fasting) sample
Measured using ELISA from venous blood samples
Baseline (fasting) sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loughborough University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College, London
National Institute for Health Research, United Kingdom
Rosetrees Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David J Stensel, PhD, Loughborough University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R14-P143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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