HealthyNCT04302285
Impact of Single Exercise Session Conducted Prior to PKU Type Meal on Appetite Hormones and Energy Intake
A study testing PKU type meal and Exercise and PKU type meal in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The study applied a randomized, crossover design with preliminary (screening) session and two sequenced experimental trials. Trials were marked as Control trial and Exercise trial. Participants were asked to either resting (Control trial) or exercising (Exercise trial) for one hour. Read more about this study
- Who is it for?
- Ages 22 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PKU type meal and Exercise and PKU type meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jun 2018to 5 Jul 2019
- 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 22 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men with
- Body mass index (BMI) ≤29 kg/m2
- Aged 22-35 years
- Stable body weight for one month prior to study enrolment, and were
- Not taking any medication, nutritional supplement or being on a special diet.
Who cannot join
- Smokers
- Chronic illness
- Eating disorder
- History of gastrointestinal operations which could interfere with the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Single Exercise Session Conducted Prior to Phenylketonuria (PKU) Type Meal on Appetite Hormones, Metabolic Rate, Fat Oxidation and Energy Intake
The study applied a randomized, crossover design with preliminary (screening) session and two sequenced experimental trials. Trials were marked as Control trial and Exercise trial. Participants were asked to either resting (Control trial) or exercising (Exercise trial) for one hour. In the two trials, appetite questionnaires were obtained, blood samples were collected, and metabolic rates were measured every 30 minutes. Participants in both trials were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal at 300 min. Participants required to record their EI for the remainder of the experimental day using a self-recorded food diary. Two days prior the experimental trials participants refrained from exercise and alcohol intake. All data collection took place in the metabolic research unit at New Lister Building, Glasgow Royal Infirmary.
Read the detailed description
Participants of the study were essentially healthy men with body mass index (BMI) ≤29 kg/m2 and aged between 22-35 years, recruited by advertisements and word of mouth. Study participants were required to be non-smokers, to have stable body weight for one month prior to study enrolment, and were not taking any medication, nutritional supplement or being on a special diet. Exclusion criteria included chronic illness, eating disorder and history of gastrointestinal operations which could interfere with the results of the study. Written informed consent were obtained prior commencing the study. The Ethics Committee of the collage of Medical Veterinary and Life Sciences, Glasgow University approved the study.
Preliminary session
Before joining the study, preliminary session was conducted for ~3 hours. Participants were informed to come to the metabolic research unit at New Lister Building, Glasgow Royal Infirmary to completed physical activity readiness questionnaire (PARQ), healthy screening questionnaire and International physical activity questionnaire. Only participants at light or moderate of physical activity level, answered "no" to all questions in PARQ and were in generally good health were eligible to complete the preliminary session. Subsequently, height and body mass were measured and a ~30 min submaximal exercise test was conducted at gradually increasing inclines. After 4 minutes of warming up period (3.5 km/hr and 0% incline), participants were walking at a constant speed of 6 km/hr with incline being increased by 2% every 4 min. The test was terminated when the heart rate (HR) reached 85% of maximal HR (HRmax) defined as 220 - age in years. During the test, participants were wearing a HR monitor and a face mask (to measure rate of oxygen consumption (V̇O2) and rate of carbon dioxide production (V̇CO2)). The HR monitor and the mask were both connected to the indirect calorimetry machine (Quark RMR®, COSMED, Italy). The obtained data was used to predict maximal oxygen consumption (V̇O2max) which was achieved by extrapolation of the HR against V̇O2 in order to calculate workload corresponds to 60% of V̇O2max.
Experimental trials
A randomisation scheme was generated using GraphPad Software 2018© to allocate participants to the experimental trials. Trials were marked as Control and Exercise by the researcher. Each participant started first trial according to allocated trial randomization. On the morning of each experiment trial, participants reported to the metabolic research unit between 08:00 and 09:00 after an overnight fast. Height, body mass and resting metabolic rate (RMR) were measured. A cannula was introduced into an antecubital vein and after an interval of 10 min, a baseline blood sample was obtained. Subsequently, an appetite questionnaire was completed. Participants were then asked to either resting (Control trial) or exercising (Exercise trial) for one hour. The Exercise trials were conducted under controlled laboratory conditions. Participants were exercising on the treadmill (Trackmaster Treadmills, Full Vision, Inc., Kansas, USA) at speed and grade corresponding to 60% of their V̇O2max. Participants were wearing a HR monitor and a face mask while exercising, connected to indirect calorimetry equipment (Quark RMR®, COSMED, Italy). V̇O2 and V̇CO2 in the inspired and expired air were measured to calculate fat and CHO oxidation and rate of physical activity energy expenditure (PAEE) by using indirect calorimetry equations described by Frayn and Macdonald (1997).
Subsequently, participants in both trials were presented to a standard isocaloric PKU type meal at 120 min. PKU meals in Exercise and Control trials were matched for weight content and macronutrient composition. Participants were asked to consume the entire meal within 20 min. Appetite questionnaires were obtained and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal which used to assess, under laboratory conditions, the spontaneous macronutrient and energy intake (EI). After completion of each trial, participants required to record their EI for the remainder of the experimental day using a self-recorded food diary. Water was available throughout the trials, but intake was replicated in the second trial and consumption time was matched. During the two days before the first trial, participants weighed and recorded all foods and drinks consumed and were asked to replicate this intake during the two days preceding the second trial.
- Conditions
- Healthy
- Being tested
- PKU type meal and Exercise, PKU type meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PKU type meal and ExerciseOther
- Exercise was conducted prior to PKU type meal.
- PKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat.
PKU type mealOther
PKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat.
| Study group | Role | What they receive |
|---|---|---|
| Exercise trial | Experimental | In this trial, participants were asked to exercise for one hour under controlled laboratory conditions. Participants were exercising on the treadmill at speed and grade corresponding to 60% of their V̇O2max. Participants were wearing a HR monitor and a face mask while exercising, connected to indirect calorimetry equipment. Appetite questionnaires were obtained, and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. Participants were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal. Receives: Other: PKU type meal and Exercise |
| Control trial | Experimental | In this trial, participants were asked to rest for one hour. Appetite questionnaires were obtained, and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. Participants were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal. Receives: Other: PKU type meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peptide YY (PYY)
Changes in plasma concentration of fasting and postprandial PYY were measured during the Exercise and Control trials.
Measured: 300 minutes through study completion, an average of 12 days
Glucagon-like peptide-1 (GLP-1)
Changes in plasma concentration of fasting and postprandial GLP-1 were measured during the Exercise and Control trials.
Measured: 300 minutes through study completion, an average of 12 days
Secondary outcomes (5)
Subjective appetite score
Appetite scores during Exercise and Control trials were 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: 300 minutes through study completion, an average of 12 days
Dietary intake
Energy and macronutrient intake during Exercise and Control trials was analysed using WinDiets software based on food composition tables.
Measured: 24 hours through study completion, an average of 12 days
Diet induced thermogenesis
Metabolic rate measured during Exercise and Control trials by means of indirect calorimetry
Measured: 300 minutes through study completion, an average of 12 days
Growth differentiation factor 15 (GDF-15)
Changes in plasma concentration of fasting and postprandial GDF-15 were measured during the Exercise and Control trials.
Measured: 300 minutes through study completion, an average of 12 days
Fat oxidation
Rate of fat oxidation during Exercise and Control trials was measured by means of indirect calorimetry
Measured: 300 minutes through study completion, an average of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start3 Jun 2018
- Primary completion4 Jun 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 16 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
- NCT04302285
- Sponsor's protocol ID
- 200170151
- Status last verified
- Mar 2020
- First submitted
- 4 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Single Exercise Session Conducted Prior to Phenylketonuria (PKU) Type Meal on Appetite Hormones, Metabolic Rate, Fat Oxidation and Energy Intake
- ClinicalTrials.gov ID
- NCT04302285
- Acronym / sponsor ID
- 200170151
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 3 Jun 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 10 Mar 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.
The study applied a randomized, crossover design with preliminary (screening) session and two sequenced experimental trials. Trials were marked as Control trial and Exercise trial. Participants were asked to either resting (Control trial) or exercising (Exercise trial) for one hour. In the two trials, appetite questionnaires were obtained, blood samples were collected, and metabolic rates were measured every 30 minutes. Participants in both trials were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal at 300 min. Participants required to record their EI for the remainder of the experimental day using a self-recorded food diary. Two days prior the experimental trials participants refrained from exercise and alcohol intake. All data collection took place in the metabolic research unit at New Lister Building, Glasgow Royal Infirmary.
Detailed description
Participants of the study were essentially healthy men with body mass index (BMI) ≤29 kg/m2 and aged between 22-35 years, recruited by advertisements and word of mouth. Study participants were required to be non-smokers, to have stable body weight for one month prior to study enrolment, and were not taking any medication, nutritional supplement or being on a special diet. Exclusion criteria included chronic illness, eating disorder and history of gastrointestinal operations which could interfere with the results of the study. Written informed consent were obtained prior commencing the study. The Ethics Committee of the collage of Medical Veterinary and Life Sciences, Glasgow University approved the study.
Preliminary session
Before joining the study, preliminary session was conducted for ~3 hours. Participants were informed to come to the metabolic research unit at New Lister Building, Glasgow Royal Infirmary to completed physical activity readiness questionnaire (PARQ), healthy screening questionnaire and International physical activity questionnaire. Only participants at light or moderate of physical activity level, answered "no" to all questions in PARQ and were in generally good health were eligible to complete the preliminary session. Subsequently, height and body mass were measured and a ~30 min submaximal exercise test was conducted at gradually increasing inclines. After 4 minutes of warming up period (3.5 km/hr and 0% incline), participants were walking at a constant speed of 6 km/hr with incline being increased by 2% every 4 min. The test was terminated when the heart rate (HR) reached 85% of maximal HR (HRmax) defined as 220 - age in years. During the test, participants were wearing a HR monitor and a face mask (to measure rate of oxygen consumption (V̇O2) and rate of carbon dioxide production (V̇CO2)). The HR monitor and the mask were both connected to the indirect calorimetry machine (Quark RMR®, COSMED, Italy). The obtained data was used to predict maximal oxygen consumption (V̇O2max) which was achieved by extrapolation of the HR against V̇O2 in order to calculate workload corresponds to 60% of V̇O2max.
Experimental trials
A randomisation scheme was generated using GraphPad Software 2018© to allocate participants to the experimental trials. Trials were marked as Control and Exercise by the researcher. Each participant started first trial according to allocated trial randomization. On the morning of each experiment trial, participants reported to the metabolic research unit between 08:00 and 09:00 after an overnight fast. Height, body mass and resting metabolic rate (RMR) were measured. A cannula was introduced into an antecubital vein and after an interval of 10 min, a baseline blood sample was obtained. Subsequently, an appetite questionnaire was completed. Participants were then asked to either resting (Control trial) or exercising (Exercise trial) for one hour. The Exercise trials were conducted under controlled laboratory conditions. Participants were exercising on the treadmill (Trackmaster Treadmills, Full Vision, Inc., Kansas, USA) at speed and grade corresponding to 60% of their V̇O2max. Participants were wearing a HR monitor and a face mask while exercising, connected to indirect calorimetry equipment (Quark RMR®, COSMED, Italy). V̇O2 and V̇CO2 in the inspired and expired air were measured to calculate fat and CHO oxidation and rate of physical activity energy expenditure (PAEE) by using indirect calorimetry equations described by Frayn and Macdonald (1997).
Subsequently, participants in both trials were presented to a standard isocaloric PKU type meal at 120 min. PKU meals in Exercise and Control trials were matched for weight content and macronutrient composition. Participants were asked to consume the entire meal within 20 min. Appetite questionnaires were obtained and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal which used to assess, under laboratory conditions, the spontaneous macronutrient and energy intake (EI). After completion of each trial, participants required to record their EI for the remainder of the experimental day using a self-recorded food diary. Water was available throughout the trials, but intake was replicated in the second trial and consumption time was matched. During the two days before the first trial, participants weighed and recorded all foods and drinks consumed and were asked to replicate this intake during the two days preceding the second trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise trial | Experimental | Other: PKU type meal and ExerciseIn this trial, participants were asked to exercise for one hour under controlled laboratory conditions. Participants were exercising on the treadmill at speed and grade corresponding to 60% of their V̇O2max. Participants were wearing a HR monitor and a face mask while exercising, connected to indirect calorimetry equipment. Appetite questionnaires were obtained, and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. Participants were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal. |
| Control trial | Experimental | Other: PKU type mealIn this trial, participants were asked to rest for one hour. Appetite questionnaires were obtained, and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. Participants were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal. |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men with
- Body mass index (BMI) ≤29 kg/m2
- Aged 22-35 years
- Stable body weight for one month prior to study enrolment, and were
- Not taking any medication, nutritional supplement or being on a special diet.
Key exclusion criteria (4 listed)
- Smokers
- Chronic illness
- Eating disorder
- History of gastrointestinal operations which could interfere with the results of the study
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 |
|---|---|---|
| PKU type meal and Exercise* Exercise was conducted prior to PKU type meal. * PKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat. | Other | Exercise trial |
| PKU type mealPKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat. | Other | Control trial |
Primary outcome
Peptide YY (PYY)
Time frame: 300 minutes through study completion, an average of 12 days
Changes in plasma concentration of fasting and postprandial PYY were measured during the Exercise and Control trials.
Glucagon-like peptide-1 (GLP-1)
Time frame: 300 minutes through study completion, an average of 12 days
Changes in plasma concentration of fasting and postprandial GLP-1 were measured during the Exercise and Control trials.
5 secondary outcomes
Subjective appetite score
Time frame: 300 minutes through study completion, an average of 12 days
Dietary intake
Time frame: 24 hours through study completion, an average of 12 days
Diet induced thermogenesis
Time frame: 300 minutes through study completion, an average of 12 days
Growth differentiation factor 15 (GDF-15)
Time frame: 300 minutes through study completion, an average of 12 days
Fat oxidation
Time frame: 300 minutes through study completion, an average of 12 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 10 Mar 2020.
- Individual participant dataSharing planned: No
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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 PKU type meal and Exercise and PKU type meal in people with Healthy, 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 5 inclusion and 4 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 10 Mar 2020. 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?
Peptide YY (PYY) (time frame: 300 minutes through study completion, an average of 12 days). The study lists 2 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 10 Mar 2020.