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Determinants of Post-Exercise Eating Patterns (DEEP)

23 de julio de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Singapore, Singapur, Singapore 11760
        • Reclutamiento
        • Clinical Nutrition Research Centre
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 40 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Masculino

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de septiembre de 2018

Finalización primaria (Anticipado)

1 de septiembre de 2019

Finalización del estudio (Anticipado)

1 de septiembre de 2019

Fechas de registro del estudio

Enviado por primera vez

7 de agosto de 2018

Primero enviado que cumplió con los criterios de control de calidad

21 de agosto de 2018

Publicado por primera vez (Actual)

22 de agosto de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de julio de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

23 de julio de 2019

Última verificación

1 de julio de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2017/01034

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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