- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03643315
Determinants of Post-Exercise Eating Patterns (DEEP)
Determinants of Post-Exercise Eating Patterns / Alternative Title (Cover): Effect of Pre-meal Activities on Blood Pressure in Healthy Adults
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Singapore, Singapour, Singapore 11760
- Recrutement
- Clinical Nutrition Research Centre
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Contact:
- Aaron Sim, PhD
- Numéro de téléphone: 64074046
- E-mail: aaron_sim@sics.a-star.edu.sg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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 |
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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.
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30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
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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)
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30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
Délai: 3 hours
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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)
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3 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Appetite-related blood hormone concentration in response to experimental conditions.
Délai: 3 hours
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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.
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3 hours
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Metabolic blood variable concentration in response to experimental conditions
Délai: 3 hours
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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.
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3 hours
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Subjective ratings of hunger in response to experimental conditions
Délai: 3 hours
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Self-reported subjective ratings of hunger will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales.
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3 hours
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Subjective ratings of satiation (fullness) in response to experimental conditions
Délai: 3 hours
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Self-reported subjective ratings of satiation (fullness) will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales
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3 hours
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Subjective ratings of desire to eat in response to experimental conditions
Délai: 3 hours
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Self-reported subjective ratings of desire to eat will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales
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3 hours
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Subjective ratings of prospective food consumption in response to experimental conditions
Délai: 3 hours
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Self-reported subjective ratings of prospective food consumption will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales.
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3 hours
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Free-living energy intake (1 day post-experiment) in response to experimental conditions
Délai: 1 day
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1 day free-living energy intake (self-report)
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1 day
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Free-living physical activity levels intake (1 day post-experiment) in response to experimental conditions
Délai: 1 day
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1 day free-living physical activity levels (physical activity monitors)
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1 day
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Self-reported tendencies of compensatory health beliefs
Délai: Assessed at start of study - through study completion - up to 4-5 weeks
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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
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Self-reported tendencies of licensing/reward beliefs
Délai: Assessed at start of study - through study completion - up to 4-5 weeks
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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
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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
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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
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Self-reported assessment of motivation (regulation) to exercise
Délai: Assessed at start of study - through study completion - up to 4-5 weeks
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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
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Self-reported assessment of motivation to eat healthily
Délai: Assessed at start of study - through study completion - up to 4-5 weeks
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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
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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
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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
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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
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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
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Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
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) ?
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
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