Carbohydrate Intake and Gut Hormone Release During Exercise

August 7, 2024 updated by: Imperial College London

It is well known that following a single session of moderate-to-high intensity exercise individuals experience a temporary suppression of hunger and a delay in the commencement of eating. This effect is believed to be due to changes in blood concentrations of specific hormones released from the gut that influence appetite.

Individuals undertaking physical activity often consume foods immediately before exercise in order to improve their performance. However, it is currently unknown whether this eating practice influences the gut hormone response to exercise as well as how hungry an individual feels post-exercise.

Therefore, the aim of this study is to investigate the effect of consuming a sugary (carbohydrate) drink immediately before starting an exercise session on the concentration of these gut hormones as well as the amount of food eaten in the hours following exercise completion.

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

It is well established that following an acute bout of moderate-to-high intensity exercise individuals experience a transient suppression of hunger and a delay in the commencement of eating - a phenomenon referred to as exercise-induced anorexia. Acute exercise modulates the concentrations of gut hormones known to influence satiety, including the anorexigenic hormones glucagon-like peptide 1 (GLP-1) and peptide tyrosine tyrosine (PYY), as well as the acylated form of the orexigenic hormone ghrelin. These alterations in gut hormone concentrations have consequently been hypothesised to play a key role in exercise-induced anorexia.

Despite suppressing hunger and delaying eating, acute exercise does not appear to alter short-term energy intake in the immediate hours following exercise completion. The absence of a compensatory response therefore creates an energy deficit capable of inducing weight loss. Strategies that augment the gut hormone response to acute exercise may thus increase the potency of exercise as a weight-loss tool.

Research investigating the effect of exercise on appetite has frequently utilised participants in a fasting state. Undertaking exercise in this physiological condition contradicts current practices, as athletes often consume a carbohydrate source immediately prior to exercise in an attempt to maximise performance. It is currently unknown as to whether the consumption of carbohydrate during this period may further enhance the gut hormone response to exercise, and thus research into a potential additive effect is warranted.

High-intensity exercise increases sympathetic nervous system activity and catecholamine release. Catecholamine concentrations are negatively correlated with acylated ghrelin concentrations and may directly stimulate GLP-1 and PYY release via activation of β-receptors located on L-cells. The decrease in gastric emptying rate that is observed during high-intensity exercise is also attributed to this increase in sympathetic activity. Consequently, an increase in sympathetic nervous system activity has been postulated as a key mechanism underlying exercise-induced changes in gut hormone concentrations. However, to our knowledge, no study has directly measured the relationship between sympathetic nervous system activity and anorexigenic gut hormone release during exercise.

Therefore, the aim of this study is to examine any potential additive effects of carbohydrate ingestion immediately prior to exercise on gut hormone release and post-exercise appetite suppression. Furthermore, this study will look to investigate the mechanisms underlying changes in gut hormone concentrations experienced during exercise.

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.
12

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
      • London, United Kingdom, W12 0HS
        • Imperial Clinical Research Facility

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male
  • Age between 18-40 years (inclusive)
  • Body mass index (BMI) of 18-30 kg/m2
  • Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements

Exclusion Criteria:

  • Abnormal ECG
  • Screening blood results outside of normal reference values
  • Current smokers
  • Current or history of substance abuse and/or excess alcohol intake
  • Diabetes
  • Cardiovascular disease
  • Cancer
  • Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
  • Kidney disease
  • Liver disease
  • Pancreatitis
  • Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
  • Participation in a research study in the 12 week period prior to entering this study.
  • Any blood donation within the 12 week period prior to entering this study

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 Assignment
  • Masking: Double

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.
Placebo Comparator: No Carbohydrate Drink + Rest
Participants will consume the no carbohydrate drink (300ml water) followed by a rest session
Other: Rest
30 minutes laying on a bed
Other: Water
A drink containing 300ml of water
Active Comparator: No Carbohydrate Drink + Exercise
Participants will consume the no carbohydrate drink (300ml water) followed by an exercise session (75% VO2 max on a cycle ergometer)
Other: Water
A drink containing 300ml of water
Other: Exercise
30 minutes on a cycle ergometer working at 75% VO2 max
Active Comparator: Carbohydrate Drink + Rest
Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by a rest session
Other: Rest
30 minutes laying on a bed
Dietary supplement: Maltodextrin (carbohydrate)
A drink containing 300ml of water and 75g of maltodextrin
Experimental: Carbohydrate Drink + Exercise
Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by an exercise session (75% VO2 max on a cycle ergometer)
Other: Exercise
30 minutes on a cycle ergometer working at 75% VO2 max
Dietary supplement: Maltodextrin (carbohydrate)
A drink containing 300ml of water and 75g of maltodextrin

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
Changes in GLP-1 concentration
Time Frame: During the study visit, 165 minutes
Changes in GLP-1 concentration between exercise and resting conditions, and between carbohydrate and control conditions
During the study visit, 165 minutes
Changes in PYY concentration
Time Frame: During the study visit, 165 minutes
Changes in PYY concentration between exercise and resting conditions, and between carbohydrate and control conditions
During the study visit, 165 minutes
Changes in acylated ghrelin concentration
Time Frame: During the study visit, 165 minutes
Changes in acylated ghrelin concentration between exercise and resting conditions, and between carbohydrate and control conditions
During the study visit, 165 minutes

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
Changes in energy intake
Time Frame: During the study visit, 165 minutes
Differences in energy intake at an ad libitum meal between exercise and resting conditions, and between carbohydrate and control conditions
During the study visit, 165 minutes
Changes in Energy expenditure
Time Frame: During the study visit, 165 minutes
Differences in energy expenditure between exercise and resting conditions, and between carbohydrate and control conditions.
During the study visit, 165 minutes
Changes in energy balance
Time Frame: During the study visit, 165 minutes
Differences in energy balance between exercise and resting conditions, and between carbohydrate and control conditions.
During the study visit, 165 minutes
Glucose homeostasis
Time Frame: During the study visit, 165 minutes
Changes in glucose homeostasis between exercise and resting conditions, and between carbohydrate and control conditions.
During the study visit, 165 minutes
Changes in subjective nausea
Time Frame: During the study visit, 165 minutes
Changes in subjective feelings of nausea as measured by visual analogue scales between exercise and resting conditions, and between carbohydrate and control conditions. Visual analogue scales will range from 0 mm to 100 mm with a higher score indicating a higher degree of nausea.
During the study visit, 165 minutes
Changes in subjective appetite
Time Frame: During the study visit, 165 minutes
Changes in subjective feelings of appetite as measured by visual analogue scales between exercise and resting conditions, and between carbohydrate and control conditions. Visual analogue scales will range from 0 mm to 100 mm with a higher score indicating a higher degree of fullness.
During the study visit, 165 minutes

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.
Imperial College London

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: Edward Chambers, PhD, Imperial College London

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 (Actual)

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.
February 21, 2019

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.
February 12, 2020

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.
February 12, 2020

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).
July 9, 2019

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.
July 12, 2019

First Posted (Actual)

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.
July 15, 2019

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.
August 9, 2024

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.
August 7, 2024

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.
August 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 18HH4889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No: There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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