Gastrointestinal HormonesNCT04249609
Composition of Meals Around Exercise Session
A study testing HCHO meals and exercise and LCHO meals and exercise in people with Gastrointestinal Hormones, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
This will be a randomised cross-over study where participants will be asked to undergo screening session followed by submaximal exercise test and then undergo 2 experimental trials, one high CHO trial and another high fat trial, each lasting over 2 days. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Hormones
- What is being tested?
- HCHO meals and exercise and LCHO meals and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2019to 5 Aug 2022
- 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 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy sedentary males aged between 25-35 years with body mass index (BMI) 25- 30 kg/m2
- participants with stable body weight for at least 3 months.
Who cannot join
- Smokers, suffering from food allergy, on any dietary supplements or dietary regimes at the time of the study
- Participants with systolic/diastolic <90/60 mmHg and >140/90 mmHg or with history of chronic illness.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Nutrition, College of Medicine, Veterinary and Life Science
Glasgow, G31 2ER
About this study
Official title: The Effect of Macronutrient Composition of Meals Consumed Around a Single Exercise Session of Subjective Appetite, Appetite Hormones and Daily Energy Intake in Overweight Men
This will be a randomised cross-over study where participants will be asked to undergo screening session followed by submaximal exercise test and then undergo 2 experimental trials, one high CHO trial and another high fat trial, each lasting over 2 days. On Day 1 participants will consume either high CHO or high fat evening meal and on Day 2 they will be exercising for 60 minutes in the fasted state and then consume either high CHO or high fat morning meal and then 5 hours after morning meal ad libitum buffet meal. After this, they will leave metabolic investigation room and will record all food and drinks consumed during the rest of the day. The washout period between the trials will be at least 7 days. Prior to each of the experimental trials, participants will be asked to avoid consumption of coffee and alcohol for the duration of 2 days. All data collection will all take place in the metabolic research unit at New Lister Building (NLB), Glasgow Royal infirmary (GRI).
Read the detailed description
The researcher will enrol eligible participants by means of an advertisement leaflet and word of mouth in the campus of the University of Glasgow and other major public areas. Those who show interest about the study will be contacted by the researcher who will explain the study in detail and will give them a copy of the participant information leaflet. If the participant is happy to participate, he will sign an informed consent form and privacy notes. Only participants with stable body weight for at least 3 months will be recruited and we will exclude those who are on positive or negative energy balance (recent weight gain or loss, ±2 kg the past month).
As part of the screening process, each participant will be asked to fill in Physical Activity Readiness Questionnaire (PARQ) and Health Screening Questionnaire. Only those who answered "no" to all questions in PARQ and were in generally good health will carry on with other aspects of the study. These questionnaires will be completed during screening session, which will take place at NLB, GRI. Height and body weigh will be measured at the screening session. Only those with BMI between 25.0-30 kg/m2 will be invited to participate. Smokers will not be recruited. It will be explained that their participation is voluntary, that they may withdraw at any point if they wish, and that the data collected will be anonymised. We will thank those subjects who have expressed an interest about the study but do not qualify and we will explain to them why they need to be excluded. Those who are eligible to participate will be enrolled in the trial which will last for 4 weeks and we will measure their height and weight.
Main Experimental Trials:
The experimental trials will last over 2 days. On day 1 Participants will consume provided dinner and on Day2 attend the metabolic research unit at New Lister Building of the Royal Infirmary in the fasted state at approximately 09:00 am. An intravenous cannula will be placed by a trained phlebotomist upon arrival. This will be used to draw blood samples throughout trial. After the collection of the first blood sample, the participant will walk on the treadmill at speed and grade corresponding to 55% of their maximal oxygen consumption. During exercise, participants will be wearing a heart rate monitor and a face mask connected to indirect calorimetry equipment to allow measurements of fat and CHO oxidation Ratings of perceived exertion will be recorded at every 10 minutes. Following exercise, participants will rest for 60 minutes and then either high CHO or high fat morning meal will be provided. Further blood samples will be collected for the duration of 5-hours; in total no more than 70 ml of blood will be taken during each of the trials. Following the last blood sample collection, participants will eat from ad libitum buffet and then leave laboratory and during the rest of the day will be recording all food and drink consumed.
Meal On day 1 dinner meal will provided with either high carbohydrate or high fat meal which contains 35% of participants total daily energy intakes. In high CHO trial, meal will consist of pasta, meat ball and orange juice. In high fat trial, meals will be based on burger, cheese, mushroom, nuts, and butter. On the day 2 and after 60 minutes exercise, participants will consume morning meal, providing 30% of their total daily energy intake. In high fat trial, morning meals will be based on white bread, peanut butter, nuts, and olives. In high CHO trial, meal will consist of oats, skimmed milk, banana and seedless raisins.
Exercise Tests Participants will conduct a submaximal exercise test to estimate their maximal oxygen consumption (V̇O2 max), a marker of cardiorespiratory fitness. During the main experimental trials, participants will undergo a 60-minute walking exercise at a predetermined work rate corresponding to 55% of their predicted V̇O2 max. Both exercise sessions will be conducted on a treadmill and will be at intensity below 85% of maximal HR. Heart rate and ratings of perceived exertion will be recorded throughout the test via a heart rate monitor.
Preparation for experimental trials Participants will be asked to record dietary intake for 2 days prior to the first experimental trial and will be asked to replicate this in the 2 days prior to the second experimental trial. Prior to both experimental trials participants will be asked to avoid consumption of coffee and alcohol for the duration of 3 days.
- Conditions
- Gastrointestinal Hormones
- Being tested
- HCHO meals and exercise, LCHO meals and exercise
- Keywords
- Exercise, Appetite, Gastrointestinal hormones, Macronutrient, Fat oxidation, Thermic effect of food, Energy intake
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCHO meals and exerciseOther
Also called High carbohydrate meals and exercise
Exercise will be conducted after high carbohydrate dinner and prior to high carbohydrate breakfast
LCHO meals and exerciseOther
Also called Low Carbohydrate and exercise Intervention
Exercise will be conducted after high fat dinner and prior to high fat breakfast
| Study group | Role | What they receive |
|---|---|---|
| High Carbohydrate Meals Around Exercise | Experimental | On day 1, high CHO dinner meal will provide 35% of participants total daily energy requirements. Meal will consist of pasta, meat ball and orange juice. On the day 2, participants will exercise for 60 minutes and then in 60 minutes will consume morning meal, providing 30% of their total daily energy requirements. Morning meal will consist of oats, skimmed-milk, banana and seedless raisins. Receives: Other: HCHO meals and exercise |
| Low Carbohydrate Meals Around Exercise | Experimental | On day 1, low CHO dinner meal will provide 35% of participants total daily energy requirements. Meal will based on burger, cheese, mushroom, nuts, and butter.On the day 2, participants will exercise fro 60 minutes and then in 60 will consume morning meal, providing 30% of their total daily energy requirements. Meal will consist of white bread, egg, cheese, olive oil, nuts, and olives. Receives: Other: LCHO meals and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite Hormones: Glucagon like peptide (GLP-1)
Plasma concentration during HCHO and LCHO trials
Measured: 420 minutes through study completion, an average of 10 days
Appetite Hormone: Peptide YY (PYY)
Plasma concentration during HCHO and LCHO trials
Measured: 420 minutes through study completion, an average of 10 days
Growth Differentiation Factor-15 (GDF 15)
Plasma concentration during HCHO and LCHO trials
Measured: 420 minutes through study completion, an average of 10 days
Secondary outcomes (7)
Insulin
Plasma concentration during HCHO and LCHO trials
Measured: 420 minutes through study completion, an average of 10 days
Glucose
Plasma concentration during HCHO and LCHO trials
Measured: 420 minutes through study completion, an average of 10 days
Triglycerides
Plasma concentration during HCHO and LCHO trials
Measured: 420 minutes through study completion, an average of 10 days
Subjective appetite scores
Appetite scores during HCHO and LCHO trials will be assessed using a 100-mm Visual Analog Scale, with 0 mm meaning one and 100 mm another extreme of hunger, desire to eat, fullness, prospective food consumption, and satiety.
Measured: 420 minutes through study completion, an average of 10 days
Diet induced thermogenesis
Metabolic rate measured during HCHO and LCHO trials by means of indirect calorimetry
Measured: 420 minutes through study completion, an average of 10 days
Dietary intake
Energy and macronutrient intake during HCHO and LCHO trial will analyses using WinDiets software based on food composition tables.
Measured: 24 hr through study completion, an average of 10 days
Energy substrate oxidation
Rate of carbohydrate and fat oxidation during HCHO and LCHO trials by means of indirect calorimetry
Measured: 420 minutes through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start23 Apr 2019
- Primary completion2 Jun 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HormonesStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dalia Malkova, University of Glasgow
- Investigators
- Dalia Malkova, PhD, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249609
- Sponsor's protocol ID
- 200180122
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2019
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Macronutrient Composition of Meals Consumed Around a Single Exercise Session of Subjective Appetite, Appetite Hormones and Daily Energy Intake in Overweight Men
- ClinicalTrials.gov ID
- NCT04249609
- Acronym / sponsor ID
- 200180122
- Conditions
- Gastrointestinal Hormones
- Keywords
- Exercise, Appetite, Gastrointestinal hormones, Macronutrient, Fat oxidation, Thermic effect of food, Energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 31 Jan 2020 (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.
This will be a randomised cross-over study where participants will be asked to undergo screening session followed by submaximal exercise test and then undergo 2 experimental trials, one high CHO trial and another high fat trial, each lasting over 2 days. On Day 1 participants will consume either high CHO or high fat evening meal and on Day 2 they will be exercising for 60 minutes in the fasted state and then consume either high CHO or high fat morning meal and then 5 hours after morning meal ad libitum buffet meal. After this, they will leave metabolic investigation room and will record all food and drinks consumed during the rest of the day. The washout period between the trials will be at least 7 days. Prior to each of the experimental trials, participants will be asked to avoid consumption of coffee and alcohol for the duration of 2 days. All data collection will all take place in the metabolic research unit at New Lister Building (NLB), Glasgow Royal infirmary (GRI).
Detailed description
The researcher will enrol eligible participants by means of an advertisement leaflet and word of mouth in the campus of the University of Glasgow and other major public areas. Those who show interest about the study will be contacted by the researcher who will explain the study in detail and will give them a copy of the participant information leaflet. If the participant is happy to participate, he will sign an informed consent form and privacy notes. Only participants with stable body weight for at least 3 months will be recruited and we will exclude those who are on positive or negative energy balance (recent weight gain or loss, ±2 kg the past month).
As part of the screening process, each participant will be asked to fill in Physical Activity Readiness Questionnaire (PARQ) and Health Screening Questionnaire. Only those who answered "no" to all questions in PARQ and were in generally good health will carry on with other aspects of the study. These questionnaires will be completed during screening session, which will take place at NLB, GRI. Height and body weigh will be measured at the screening session. Only those with BMI between 25.0-30 kg/m2 will be invited to participate. Smokers will not be recruited. It will be explained that their participation is voluntary, that they may withdraw at any point if they wish, and that the data collected will be anonymised. We will thank those subjects who have expressed an interest about the study but do not qualify and we will explain to them why they need to be excluded. Those who are eligible to participate will be enrolled in the trial which will last for 4 weeks and we will measure their height and weight.
Main Experimental Trials:
The experimental trials will last over 2 days. On day 1 Participants will consume provided dinner and on Day2 attend the metabolic research unit at New Lister Building of the Royal Infirmary in the fasted state at approximately 09:00 am. An intravenous cannula will be placed by a trained phlebotomist upon arrival. This will be used to draw blood samples throughout trial. After the collection of the first blood sample, the participant will walk on the treadmill at speed and grade corresponding to 55% of their maximal oxygen consumption. During exercise, participants will be wearing a heart rate monitor and a face mask connected to indirect calorimetry equipment to allow measurements of fat and CHO oxidation Ratings of perceived exertion will be recorded at every 10 minutes. Following exercise, participants will rest for 60 minutes and then either high CHO or high fat morning meal will be provided. Further blood samples will be collected for the duration of 5-hours; in total no more than 70 ml of blood will be taken during each of the trials. Following the last blood sample collection, participants will eat from ad libitum buffet and then leave laboratory and during the rest of the day will be recording all food and drink consumed.
Meal On day 1 dinner meal will provided with either high carbohydrate or high fat meal which contains 35% of participants total daily energy intakes. In high CHO trial, meal will consist of pasta, meat ball and orange juice. In high fat trial, meals will be based on burger, cheese, mushroom, nuts, and butter. On the day 2 and after 60 minutes exercise, participants will consume morning meal, providing 30% of their total daily energy intake. In high fat trial, morning meals will be based on white bread, peanut butter, nuts, and olives. In high CHO trial, meal will consist of oats, skimmed milk, banana and seedless raisins.
Exercise Tests Participants will conduct a submaximal exercise test to estimate their maximal oxygen consumption (V̇O2 max), a marker of cardiorespiratory fitness. During the main experimental trials, participants will undergo a 60-minute walking exercise at a predetermined work rate corresponding to 55% of their predicted V̇O2 max. Both exercise sessions will be conducted on a treadmill and will be at intensity below 85% of maximal HR. Heart rate and ratings of perceived exertion will be recorded throughout the test via a heart rate monitor.
Preparation for experimental trials Participants will be asked to record dietary intake for 2 days prior to the first experimental trial and will be asked to replicate this in the 2 days prior to the second experimental trial. Prior to both experimental trials participants will be asked to avoid consumption of coffee and alcohol for the duration of 3 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Carbohydrate Meals Around Exercise | Experimental | Other: HCHO meals and exerciseOn day 1, high CHO dinner meal will provide 35% of participants total daily energy requirements. Meal will consist of pasta, meat ball and orange juice. On the day 2, participants will exercise for 60 minutes and then in 60 minutes will consume morning meal, providing 30% of their total daily energy requirements. Morning meal will consist of oats, skimmed-milk, banana and seedless raisins. |
| Low Carbohydrate Meals Around Exercise | Experimental | Other: LCHO meals and exerciseOn day 1, low CHO dinner meal will provide 35% of participants total daily energy requirements. Meal will based on burger, cheese, mushroom, nuts, and butter.On the day 2, participants will exercise fro 60 minutes and then in 60 will consume morning meal, providing 30% of their total daily energy requirements. Meal will consist of white bread, egg, cheese, olive oil, nuts, and olives. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy sedentary males aged between 25-35 years with body mass index (BMI) 25- 30 kg/m2
- participants with stable body weight for at least 3 months.
Key exclusion criteria (2 listed)
- Smokers, suffering from food allergy, on any dietary supplements or dietary regimes at the time of the study
- Participants with systolic/diastolic <90/60 mmHg and >140/90 mmHg or with history of chronic illness.
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 |
|---|---|---|
| HCHO meals and exerciseAlso: High carbohydrate meals and exerciseExercise will be conducted after high carbohydrate dinner and prior to high carbohydrate breakfast | Other | High Carbohydrate Meals Around Exercise |
| LCHO meals and exerciseAlso: Low Carbohydrate and exercise InterventionExercise will be conducted after high fat dinner and prior to high fat breakfast | Other | Low Carbohydrate Meals Around Exercise |
Primary outcome
Appetite Hormones: Glucagon like peptide (GLP-1)
Time frame: 420 minutes through study completion, an average of 10 days
Plasma concentration during HCHO and LCHO trials
Appetite Hormone: Peptide YY (PYY)
Time frame: 420 minutes through study completion, an average of 10 days
Plasma concentration during HCHO and LCHO trials
Growth Differentiation Factor-15 (GDF 15)
Time frame: 420 minutes through study completion, an average of 10 days
Plasma concentration during HCHO and LCHO trials
7 secondary outcomes
Insulin
Time frame: 420 minutes through study completion, an average of 10 days
Glucose
Time frame: 420 minutes through study completion, an average of 10 days
Triglycerides
Time frame: 420 minutes through study completion, an average of 10 days
Subjective appetite scores
Time frame: 420 minutes through study completion, an average of 10 days
Diet induced thermogenesis
Time frame: 420 minutes through study completion, an average of 10 days
Dietary intake
Time frame: 24 hr through study completion, an average of 10 days
Energy substrate oxidation
Time frame: 420 minutes through study completion, an average of 10 days
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 1 Aug 2023.
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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.
Dalia Malkova, PhD study chair
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCHO meals and exercise and LCHO meals and exercise in people with Gastrointestinal Hormones, run by University of Glasgow 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 2 inclusion and 2 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 1 Aug 2023. 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. 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?
Appetite Hormones: Glucagon like peptide (GLP-1) (time frame: 420 minutes through study completion, an average of 10 days). 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?
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 1 Aug 2023.