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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United Kingdom1 site
  • Univesrity of Glasgow

    Glasgow

Other trials in United Kingdom

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 groups in NCT04302285
Study groupRoleWhat they receive
Exercise trialExperimentalIn 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 trialExperimentalIn 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted10 Mar 2020
  2. Study start3 Jun 2018
  3. Primary completion4 Jun 2019
  4. Study completion5 Jul 2019

Resources

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)
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

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.

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