NCT03643315

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 27, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

August 7, 2018

Last Update Submit

July 23, 2019

Conditions

Keywords

Appetite regulationEating behaviourExerciseHIIT

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 hours

Secondary Outcomes (8)

  • Appetite-related blood hormone concentration in response to experimental conditions.

    3 hours

  • Metabolic blood variable concentration in response to experimental conditions

    3 hours

  • Subjective ratings of hunger in response to experimental conditions

    3 hours

  • Subjective ratings of satiation (fullness) in response to experimental conditions

    3 hours

  • Subjective ratings of desire to eat in response to experimental conditions

    3 hours

  • +3 more secondary outcomes

Other Outcomes (7)

  • Self-reported tendencies of compensatory health beliefs

    Assessed at start of study - through study completion - up to 4-5 weeks

  • Self-reported tendencies of licensing/reward beliefs

    Assessed at start of study - through study completion - up to 4-5 weeks

  • Self-reported tendencies and motives of compensatory eating behaviour in response to exercise

    Assessed at start of study - through study completion - up to 4-5 weeks

  • +4 more other outcomes

Study Arms (2)

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.

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)

Behavioral: No-Exercise and Meal (NEX)

Interventions

30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal

Exercise and Meal (EX)

30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal

No-Exercise and Meal (NEX)

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • Female,
  • Smoker,
  • Fasting blood glucose \> 5.9 mmol/L,
  • Resting blood pressure \> 140/90 mmHg,
  • Any major medical/health conditions including
  • Diabetes,
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, Singapore 11760, Singapore

RECRUITING

MeSH Terms

Conditions

ObesityFeeding BehaviorMotor Activity

Interventions

ExerciseMeals

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are "blind" to the true aim of the study. In addition, assignment of the experimental sessions are administered at random.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 22, 2018

Study Start

September 27, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations