ObesityNCT04019418
Carbohydrate Intake and Gut Hormone Release During Exercise
A study testing Maltodextrin (carbohydrate), Exercise and Rest in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Maltodextrin (carbohydrate), Exercise and Rest
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2019to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Clinical Research Facility
London, W12 0HS
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Maltodextrin (carbohydrate), Exercise, Rest, Water
- Keywords
- carbohydrate, exercise, PYY, GLP-1, ghrelin, hormones
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltodextrin (carbohydrate)Dietary supplement
A drink containing 300ml of water and 75g of maltodextrin
ExerciseOther
30 minutes on a cycle ergometer working at 75% VO2 max
RestOther
30 minutes laying on a bed
WaterOther
A drink containing 300ml of water
| Study group | Role | What they receive |
|---|---|---|
| No Carbohydrate Drink + Rest | Placebo comparator | Participants will consume the no carbohydrate drink (300ml water) followed by a rest session Receives: Other: Rest; Other: Water |
| No Carbohydrate Drink + Exercise | Active comparator | Participants will consume the no carbohydrate drink (300ml water) followed by an exercise session (75% VO2 max on a cycle ergometer) Receives: Other: Exercise; Other: Water |
| Carbohydrate Drink + Rest | Active comparator | Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by a rest session Receives: Dietary Supplement: Maltodextrin (carbohydrate); Other: Rest |
| Carbohydrate Drink + Exercise | Experimental | Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by an exercise session (75% VO2 max on a cycle ergometer) Receives: Dietary Supplement: Maltodextrin (carbohydrate); Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GLP-1 concentration
Changes in GLP-1 concentration between exercise and resting conditions, and between carbohydrate and control conditions
Measured: During the study visit, 165 minutes
Changes in PYY concentration
Changes in PYY concentration between exercise and resting conditions, and between carbohydrate and control conditions
Measured: During the study visit, 165 minutes
Changes in acylated ghrelin concentration
Changes in acylated ghrelin concentration between exercise and resting conditions, and between carbohydrate and control conditions
Measured: During the study visit, 165 minutes
Secondary outcomes (6)
Changes in energy intake
Differences in energy intake at an ad libitum meal between exercise and resting conditions, and between carbohydrate and control conditions
Measured: During the study visit, 165 minutes
Changes in Energy expenditure
Differences in energy expenditure between exercise and resting conditions, and between carbohydrate and control conditions.
Measured: During the study visit, 165 minutes
Changes in energy balance
Differences in energy balance between exercise and resting conditions, and between carbohydrate and control conditions.
Measured: During the study visit, 165 minutes
Glucose homeostasis
Changes in glucose homeostasis between exercise and resting conditions, and between carbohydrate and control conditions.
Measured: During the study visit, 165 minutes
Changes in subjective nausea
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.
Measured: During the study visit, 165 minutes
Changes in subjective appetite
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.
Measured: During the study visit, 165 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start21 Feb 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants perform all four trials in a randomized order
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Chambers, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019418
- Sponsor's protocol ID
- 18HH4889
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2019
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No: There is not a plan to make IPD available
Publications
Frampton J, Serrano-Contreras JI, Garcia-Perez I, Franco-Becker G, Penhaligan J, Tan ASY, de Oliveira ACC, Milner AJ, Murphy KG, Frost G, Chambers ES. The metabolic interplay between dietary carbohydrate and exercise and its role in acute appetite regulation in males: a randomized controlled study. J Physiol. 2023 Aug;601(16):3461-3480. doi: 10.1113/JP284294. Epub 2023 Jun 15.
PubMed 37269207
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Intake and Gut Hormone Release During Exercise
- ClinicalTrials.gov ID
- NCT04019418
- Acronym / sponsor ID
- 18HH4889
- Conditions
- Obesity
- Keywords
- carbohydrate, exercise, PYY, GLP-1, ghrelin, hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants perform all four trials in a randomized order
| Arm | Type | Receives |
|---|---|---|
| No Carbohydrate Drink + Rest | Placebo comparator | Other: Rest, Other: WaterParticipants will consume the no carbohydrate drink (300ml water) followed by a rest session |
| No Carbohydrate Drink + Exercise | Active comparator | Other: Exercise, Other: WaterParticipants will consume the no carbohydrate drink (300ml water) followed by an exercise session (75% VO2 max on a cycle ergometer) |
| Carbohydrate Drink + Rest | Active comparator | Dietary Supplement: Maltodextrin (carbohydrate), Other: RestParticipants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by a rest session |
| Carbohydrate Drink + Exercise | Experimental | Dietary Supplement: Maltodextrin (carbohydrate), Other: ExerciseParticipants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by an exercise session (75% VO2 max on a cycle ergometer) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Abnormal ECG
- Screening blood results outside of normal reference values
- Current smokers
- Current or history of substance abuse and/or excess alcohol intake
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maltodextrin (carbohydrate)A drink containing 300ml of water and 75g of maltodextrin | Dietary supplement | Carbohydrate Drink + Exercise, Carbohydrate Drink + Rest |
| Exercise30 minutes on a cycle ergometer working at 75% VO2 max | Other | Carbohydrate Drink + Exercise, No Carbohydrate Drink + Exercise |
| Rest30 minutes laying on a bed | Other | Carbohydrate Drink + Rest, No Carbohydrate Drink + Rest |
| WaterA drink containing 300ml of water | Other | No Carbohydrate Drink + Exercise, No Carbohydrate Drink + Rest |
Primary outcome
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
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
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
6 secondary outcomes
Changes in energy intake
Time frame: During the study visit, 165 minutes
Changes in Energy expenditure
Time frame: During the study visit, 165 minutes
Changes in energy balance
Time frame: During the study visit, 165 minutes
Glucose homeostasis
Time frame: During the study visit, 165 minutes
Changes in subjective nausea
Time frame: During the study visit, 165 minutes
Changes in subjective appetite
Time frame: During the study visit, 165 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 37269207Frampton J, Serrano-Contreras JI, Garcia-Perez I, Franco-Becker G, Penhaligan J, Tan ASY, de Oliveira ACC, Milner AJ, Murphy KG, Frost G, Chambers ES. The metabolic interplay between dietary carbohydrate and exercise and its role in acute appetite regulation in males: a randomized controlled study. J Physiol. 2023 Aug;601(16):3461-3480. doi: 10.1113/JP284294. Epub 2023 Jun 15.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Chambers, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin (carbohydrate), Exercise and Rest in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in GLP-1 concentration (time frame: During the study visit, 165 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.