- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Singapore, Singapur, Singapore 11760
- Reclutamiento
- Clinical Nutrition Research Centre
-
Contacto:
- Aaron Sim, PhD
- Número de teléfono: 64074046
- Correo electrónico: aaron_sim@sics.a-star.edu.sg
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
|
|
Experimental: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Appetite-related blood hormone concentration in response to experimental conditions.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 day
|
1 day free-living physical activity levels (physical activity monitors)
|
1 day
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-reported tendencies of compensatory health beliefs
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2017/01034
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Will be made available to other researchers upon request
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .