- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Aaron Y Sim, PhD
- Numero di telefono: +6564074046
- Email: aaron_sim@sics.a-star.edu.sg
Backup dei contatti dello studio
- Nome: Elizabeth X Lim, BSc
- Numero di telefono: +6564070093
- Email: elizabeth_lim@sics.a-star.edu.sg
Luoghi di studio
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Singapore, Singapore, Singapore 11760
- Reclutamento
- Clinical Nutrition Research Centre
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Contatto:
- Aaron Sim, PhD
- Numero di telefono: 64074046
- Email: aaron_sim@sics.a-star.edu.sg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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 |
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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.
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30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
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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)
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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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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
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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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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
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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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
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2017/01034
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Will be made available to other researchers upon request
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