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Determinants of Post-Exercise Eating Patterns (DEEP)

23 juillet 2019 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Anticipé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Singapore, Singapour, Singapore 11760
        • Recrutement
        • Clinical Nutrition Research Centre
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans à 40 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Homme

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Appetite-related blood hormone concentration in response to experimental conditions.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1 day
1 day free-living physical activity levels (physical activity monitors)
1 day

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Self-reported tendencies of compensatory health beliefs
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 septembre 2018

Achèvement primaire (Anticipé)

1 septembre 2019

Achèvement de l'étude (Anticipé)

1 septembre 2019

Dates d'inscription aux études

Première soumission

7 août 2018

Première soumission répondant aux critères de contrôle qualité

21 août 2018

Première publication (Réel)

22 août 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juillet 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 juillet 2019

Dernière vérification

1 juillet 2019

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2017/01034

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

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

Will be made available to other researchers upon request

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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