ObesityDEEPNCT03643315
Determinants of Post-Exercise Eating Patterns
A study testing Exercise and Meal (EX) and No-Exercise and Meal (NEX) in people with Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
This study examines potential physiological and psychological determinants of food intake in response to exercise. Specifically, beyond measuring actual food consumption and physiological markers typically assessed during exercise and appetite work (i.e. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise and Meal (EX) and No-Exercise and Meal (NEX)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Sep 2018to Sep 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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Inactive (< 90 min of moderate-intensity exercise a week)
- BMI: 23 and above
- Age between 21 to 40 years
- Normal fasting blood glucose levels equal to or less than 5.9 mmol/L
- Non-smoker
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- No know allergies or intolerance to food
- Not on any prescribed medication
- No physical disabilities and/or restrictions; not averse to exercising on a stationary bike or treadmill running
- No aversion to blood sampling procedures (e.g. finger prick, cannulation)
Who cannot join
- Female,
- Smoker,
- Fasting blood glucose > 5.9 mmol/L,
- Resting blood pressure > 140/90 mmHg,
- Any major medical/health conditions including
- Diabetes,
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- Metabolic disease
- Hypertension,
- Cardiovascular disease,
- Thyroid disorders,
- G6PD deficiency.
- Allergic or intolerant to foods presented in the study.
- Physical disabilities and/or restrictions.
- Individuals that are adverse to exercising on a stationary exercise bike or treadmill.
- Adverse to blood sampling procedures (i.e. cannulation, finger pricks, venepuncture).
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Clinical Nutrition Research Centre
Singapore, Singapore 11760
Aaron Sim, PhD, 64074046, aaron_sim@sics.a-star.edu.sg
About this study
Official title: Determinants of Post-Exercise Eating Patterns / Alternative Title (Cover): Effect of Pre-meal Activities on Blood Pressure in Healthy Adults
This study examines potential physiological and psychological determinants of food intake in response to exercise. Specifically, beyond measuring actual food consumption and physiological markers typically assessed during exercise and appetite work (i.e. appetite hormones, blood glucose), the investigators wish to investigate the influence of individual behavioural differences (attitudes towards eating, licensing/compensatory health beliefs, self-regulation, and exercise-associated motivation) on the relationship between exercise and eating behaviour.
- Conditions
- Obesity
- Being tested
- Exercise and Meal (EX), No-Exercise and Meal (NEX)
- Keywords
- Appetite regulation, Eating behaviour, Exercise, HIIT
- Medical subject headings
- Obesity, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Meal (EX)Behavioural
30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
No-Exercise and Meal (NEX)Behavioural
30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Meal (EX) | Experimental | The EX protocol will involve a 30 minute acute bout of high intensity intermittent exercise on a stationary exercise bike followed by an ad-libitum test meal. Receives: Behavioral: Exercise and Meal (EX) |
| No-Exercise and Meal (NEX) | Experimental | The NEX protocol will involve a 30 minute period of rest (to match the exercise period in EX) where participants will be provided a video/movie. Following this, participants will be provided ad-libitum access to a test meal (as per EX energy intake assessment protocol) Receives: Behavioral: No-Exercise and Meal (NEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
Participants' eating behaviour will be assessed by measuring the total amount of the test meal consumed in each experimental condition. The test meal will be provided ad-libitum (i.e. there will be non-restricted access)
Measured: 3 hours
Secondary outcomes (8)
Appetite-related blood hormone concentration in response to experimental conditions.
Venous blood will be sampled for the measurement of a range of appetite-related hormones including Active Ghrelin (pg/ml), Glucagon-like Peptide-1 (GLP-1) (pg/ml), Pancreatic YY (PYY) (pg/ml), Pancreatic Polypeptide (PP) (pg/ml), periodically through the experimental sessions.
Measured: 3 hours
Metabolic blood variable concentration in response to experimental conditions
Venous blood will be sampled for the measurement of metabolic blood variables blood insulin (mmol/L) and blood glucose (mmol/L) periodically through the experimental sessions.
Measured: 3 hours
Subjective ratings of hunger in response to experimental conditions
Self-reported subjective ratings of hunger will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales.
Measured: 3 hours
Subjective ratings of satiation (fullness) in response to experimental conditions
Self-reported subjective ratings of satiation (fullness) will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales
Measured: 3 hours
Subjective ratings of desire to eat in response to experimental conditions
Self-reported subjective ratings of desire to eat will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales
Measured: 3 hours
Subjective ratings of prospective food consumption in response to experimental conditions
Self-reported subjective ratings of prospective food consumption will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales.
Measured: 3 hours
Free-living energy intake (1 day post-experiment) in response to experimental conditions
1 day free-living energy intake (self-report)
Measured: 1 day
Free-living physical activity levels intake (1 day post-experiment) in response to experimental conditions
1 day free-living physical activity levels (physical activity monitors)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start27 Sep 2018
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The present study will be of a randomised counterbalanced repeated-measures (crossover) design. Each participant (n = 30) will complete four sessions; one initial screening session (remotely administered), one baseline/familiarisation session (first lab visit) and two subsequent experimental sessions (second and third lab visits). The two experimental sessions will follow a similar protocol, except that one condition will involve an exercise protocol before an ad-libitum meal (Exercise and Meal (EX) condition), and the other, a no-exercise period (rest) before an ad-libitum (NEX) control condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Nanyang Technological University
- Responsible party
- Principal investigator, Aaron Sim, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643315
- Sponsor's protocol ID
- 2017/01034
- Other IDs
- 2017
- Acronym
- DEEP
- Status last verified
- Jul 2019
- First submitted
- 7 Aug 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Will be made available to other researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Post-Exercise Eating Patterns / Alternative Title (Cover): Effect of Pre-meal Activities on Blood Pressure in Healthy Adults
- ClinicalTrials.gov ID
- NCT03643315
- Acronym / sponsor ID
- DEEP / 2017/01034
- Conditions
- Obesity
- Keywords
- Appetite regulation, Eating behaviour, Exercise, HIIT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Nanyang Technological University
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 22 Aug 2018 (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 study examines potential physiological and psychological determinants of food intake in response to exercise. Specifically, beyond measuring actual food consumption and physiological markers typically assessed during exercise and appetite work (i.e. appetite hormones, blood glucose), the investigators wish to investigate the influence of individual behavioural differences (attitudes towards eating, licensing/compensatory health beliefs, self-regulation, and exercise-associated motivation) on the relationship between exercise and eating behaviour.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The present study will be of a randomised counterbalanced repeated-measures (crossover) design. Each participant (n = 30) will complete four sessions; one initial screening session (remotely administered), one baseline/familiarisation session (first lab visit) and two subsequent experimental sessions (second and third lab visits). The two experimental sessions will follow a similar protocol, except that one condition will involve an exercise protocol before an ad-libitum meal (Exercise and Meal (EX) condition), and the other, a no-exercise period (rest) before an ad-libitum (NEX) control condition.
| Arm | Type | Receives |
|---|---|---|
| Exercise and Meal (EX) | Experimental | Behavioral: Exercise and Meal (EX)The EX protocol will involve a 30 minute acute bout of high intensity intermittent exercise on a stationary exercise bike followed by an ad-libitum test meal. |
| No-Exercise and Meal (NEX) | Experimental | Behavioral: No-Exercise and Meal (NEX)The NEX protocol will involve a 30 minute period of rest (to match the exercise period in EX) where participants will be provided a video/movie. Following this, participants will be provided ad-libitum access to a test meal (as per EX energy intake assessment protocol) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male
- Inactive (< 90 min of moderate-intensity exercise a week)
- BMI: 23 and above
- Age between 21 to 40 years
- Normal fasting blood glucose levels equal to or less than 5.9 mmol/L
Key exclusion criteria (15 listed)
- Female,
- Smoker,
- Fasting blood glucose > 5.9 mmol/L,
- Resting blood pressure > 140/90 mmHg,
- Any major medical/health conditions including
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 |
|---|---|---|
| Exercise and Meal (EX)30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal | Behavioural | Exercise and Meal (EX) |
| No-Exercise and Meal (NEX)30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal | Behavioural | No-Exercise and Meal (NEX) |
Primary outcome
Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
Time frame: 3 hours
Participants' eating behaviour will be assessed by measuring the total amount of the test meal consumed in each experimental condition. The test meal will be provided ad-libitum (i.e. there will be non-restricted access)
8 secondary outcomes
Appetite-related blood hormone concentration in response to experimental conditions.
Time frame: 3 hours
Metabolic blood variable concentration in response to experimental conditions
Time frame: 3 hours
Subjective ratings of hunger in response to experimental conditions
Time frame: 3 hours
Subjective ratings of satiation (fullness) in response to experimental conditions
Time frame: 3 hours
Subjective ratings of desire to eat in response to experimental conditions
Time frame: 3 hours
Subjective ratings of prospective food consumption in response to experimental conditions
Time frame: 3 hours
Free-living energy intake (1 day post-experiment) in response to experimental conditions
Time frame: 1 day
Free-living physical activity levels intake (1 day post-experiment) in response to experimental conditions
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: Undecided. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Will be made available to other researchers upon request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Meal (EX) and No-Exercise and Meal (NEX) in people with Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Jul 2019. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aaron Y Sim, PhD (+6564074046, aaron_sim@sics.a-star.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise). (time frame: 3 hours). 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 25 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.