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Determinants of Post-Exercise Eating Patterns (DEEP)

23 luglio 2019 aggiornato da: Aaron Sim, Clinical Nutrition Research Centre, Singapore

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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Anticipato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Singapore, Singapore, Singapore 11760

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 21 anni a 40 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
Sperimentale: 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)
30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
Lasso di tempo: 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)
3 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Appetite-related blood hormone concentration in response to experimental conditions.
Lasso di tempo: 3 hours
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.
3 hours
Metabolic blood variable concentration in response to experimental conditions
Lasso di tempo: 3 hours
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.
3 hours
Subjective ratings of hunger in response to experimental conditions
Lasso di tempo: 3 hours
Self-reported subjective ratings of hunger will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales.
3 hours
Subjective ratings of satiation (fullness) in response to experimental conditions
Lasso di tempo: 3 hours
Self-reported subjective ratings of satiation (fullness) will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales
3 hours
Subjective ratings of desire to eat in response to experimental conditions
Lasso di tempo: 3 hours
Self-reported subjective ratings of desire to eat will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales
3 hours
Subjective ratings of prospective food consumption in response to experimental conditions
Lasso di tempo: 3 hours
Self-reported subjective ratings of prospective food consumption will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales.
3 hours
Free-living energy intake (1 day post-experiment) in response to experimental conditions
Lasso di tempo: 1 day
1 day free-living energy intake (self-report)
1 day
Free-living physical activity levels intake (1 day post-experiment) in response to experimental conditions
Lasso di tempo: 1 day
1 day free-living physical activity levels (physical activity monitors)
1 day

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-reported tendencies of compensatory health beliefs
Lasso di tempo: Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported tendencies of compensatory health beliefs on the relationship between experimental conditions and study outcomes. Scale to be used:

Compensatory Health Belief (CHB) Scale, CHB Subscales: Substance use, Eating/sleeping habits, Stress and Weight regulation, Ratings on a 5-point agreement scale. Greater scores (summed) indicate greater tendency for an individual to hold compensatory beliefs (for the particular domain/subscale or collectively).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported tendencies of licensing/reward beliefs
Lasso di tempo: Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported tendencies of licensing eating behaviour in response to exercise on the relationship between experimental conditions and study outcomes. Scale to be used:

Post-Exercise Licensing (PEL)Scale. Ratings on a 7 point agreement scale. Greater scores (averaged) indicate a greater tendency to reward/license in response to exercise.

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
Lasso di tempo: Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported tendencies and motives of compensatory eating behaviour in response to exercise on the relationship between experimental conditions and study outcomes Scale to be used:

Compensatory Eating Motives Questionnaire (CEMQ) Subscales: Eating for Reward, Eating for Recovery, Eating for Relief (4 point frequency scale) Greater scores (summation of outcome of respective subscales) indicate greater tendency to compensate due to particular motive (respective subscales).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported assessment of motivation (regulation) to exercise
Lasso di tempo: Assessed at start of study - through study completion - up to 4-5 weeks

To examine the influence of self-reported motivation to exercise on the relationship between experimental conditions and study outcomes. Scale involve:

Behavioural Regulation in Exercise Questionnaire (BREQ) measures the stages of the self-determination contin. Subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation.Greater scores (averaged of outcome of respective subscale/items) indicate greater tendency for exercise behaviour to be regulated by particular construct (respective subscale).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported assessment of motivation to eat healthily
Lasso di tempo: Assessed at start of study - through study completion - up to 4-5 weeks

To examine the influence of self-reported motivation to adopt healthy eating behaviour on the relationship between experimental conditions and study outcomes. Scale involve:

Regulation of Eating Behavioural Scale (REBS). Subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation. Greater scores (averaged of outcome of respective subscale/items) indicate greater tendency for eating behaviour to be regulated by particular construct (respective subscale).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported attitudes towards eating behaviour as assessed by the Three Factor Eating Behaviour Questionnaire (TFEQ-R18)
Lasso di tempo: Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported attitudes towards eating on the relationship between experimental conditions and study outcomes. Scale involve:

Three Factor Eating Behaviour Questionnaire (TFEQ-R18) Subscales: Dietary Restraint, Uncontrolled Eating, Emotional Eating Greater scores (averaged outcome of respective subscale/items) indicate greater likelihood of the behaviour (of construct measure by respective subscales).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported weight-related behaviour change status as assessed by the Physical Activity Stages of Change Questionnaire
Lasso di tempo: Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported weight-related behaviour change status on the relationship between experimental conditions and study outcomes. Scale involve:

Physical Activity Stages of Change Questionnaire. Scores (based on scoring algorithm) will indicate participants' current stage of motivational readiness for change specific to physical activity. Greater score (1-5 representing five stages of change) indicates physical activity status and intent to be active.

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 settembre 2018

Completamento primario (Anticipato)

1 settembre 2019

Completamento dello studio (Anticipato)

1 settembre 2019

Date di iscrizione allo studio

Primo inviato

7 agosto 2018

Primo inviato che soddisfa i criteri di controllo qualità

21 agosto 2018

Primo Inserito (Effettivo)

22 agosto 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2017/01034

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

Will be made available to other researchers upon request

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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