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Alternating Energy Intake and Blood Fat Content After a Meal

25 de agosto de 2022 actualizado por: Maastricht University Medical Center

The Effect of Alternating Energy Intake Compared to Regular Energy Intake on the Fat Content in the Blood After a Meal in Abdominally Obese Adults

Increasing evidence suggests that meal timing affects metabolic health. For example, intermittent fasting (IF) may have positive effects on plasma glucose and lipid levels, insulin sensitivity, and blood pressure. However, IF protocols often result in significant weight loss. Therefore, it is not clear to what extent these beneficial metabolic effects are due to IF or to weight loss. Although the effect of IF independent of weight loss has been studied, daily energy intake in those studies did not differ between the days. Therefore, the investigators aim to examine the effect of alternating energy intake - i.e. standardised day-to-day fluctuations in energy intake - on metabolic health independent of weight loss.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

23

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Países Bajos
    • Limburg
      • Maastricht, Limburg, Países Bajos, 6229 ER
        • Reclutamiento
        • Maastricht University Medical Center
        • Contacto:
        • Investigador principal:
          • Ronald P. Mensink, PhD

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

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Apparently healthy men and women as judged by study physician
  • Abdominally obese males (waist circumference ≥ 102 cm) and females (waist circumference ≥ 88 cm)
  • Aged between 18 - 75 years
  • Stable bodyweight (weight gain or loss ≤ 3 kg in the past three months)
  • Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
  • No difficult venipuncture as evidenced during the screening visit
  • Women should be pre- or postmenopausal
  • Sedentary (light exercise < 1 h per week) or moderately active (moderate exercise 1-2 h per week)
  • Having a general practitioner
  • Agreeing that the participant and general practitioner will be informed about medically relevant personal test results by a physician
  • Willing to comply to study protocol during study
  • Informed consent signed

Exclusion Criteria:

  • Fasting plasma glucose ≥ 7 mmol/l
  • Fasting serum triacylglycerol ≥ 4.5 mmol/l
  • Fasting serum total cholesterol ≥ 8 mmol/l
  • Blood pressure ≥ 160/100 mm Hg
  • Current smoker, or smoking cessation < 12 months
  • Drug abuse
  • Alcohol abuse (≥ 21 alcohol consumptions per week)
  • Use of medication known to affect blood pressure, serum lipid metabolism, or glucose metabolism
  • Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, familiar hypercholesterolemia, liver or bowel disease or diabetes)
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
  • Use of an investigational product within another biomedical intervention trial within the previous 1-month
  • Women who are perimenopausal, have an irregular menstrual cycle, or are pregnant
  • Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator), e.g. weight loss medication
  • Reported dietary habits: medically prescribed diets or slimming diets
  • Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 AM

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Alternating energy intake schedule
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
Otro: Alternating Energy Intake
To alternate between caloric overconsumption (130% of usual total energy needs) and caloric underconsumption (70% of usual total energy needs) on a daily basis for 6 days/week followed by one ad libitum day for 4 weeks.
Comparador activo: Regular energy intake schedule
To consume the usual energy intake on a daily basis
Otro: Regular Energy Intake
To consume the usual energy intake (100% of total energy needs) on a daily basis for 6 days/week, also followed by one ad libitum day for 4 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Triacylglycerol area under the curve (AUC)
Periodo de tiempo: 4 hours
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
4 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fasting glucose metabolism
Periodo de tiempo: Baseline, week 2, and twice in week 4
Fasting glucose metabolism (includes e.g. glucose and insulin concentrations)
Baseline, week 2, and twice in week 4
Fasting lipid metabolism
Periodo de tiempo: Baseline, week 2, and twice in week 4
Fasting serum lipid and lipoprotein profile
Baseline, week 2, and twice in week 4
Marker for postprandial lipid metabolism
Periodo de tiempo: 4 hour period after consumption of a standardised mixed meal
Marker for lipid metabolism includes triacylglycerol and will be measured after consumption of a standardised mixed meal
4 hour period after consumption of a standardised mixed meal
Markers for postprandial glucose metabolism
Periodo de tiempo: 4 hour period after consumption of a standardised mixed meal
Markers for glucose metabolism include insulin and glucose and will be measured after consumption of a standardised mixed meal
4 hour period after consumption of a standardised mixed meal
24-hour glucose levels
Periodo de tiempo: 24 hours
The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor
24 hours
Day-time glucose levels
Periodo de tiempo: From 07:00 to 22:00 (15 hours)
The tAUC for day-time glucose (07:00 - 22:00 h) as measured with a continuous glucose sensor
From 07:00 to 22:00 (15 hours)
Night-time glucose levels
Periodo de tiempo: From 22:01 to 06:59 (8 hours and 58 min)
The tAUC for night-time glucose (22:01 - 06:59 h) as measured with a continuous glucose sensor
From 22:01 to 06:59 (8 hours and 58 min)
Glucose levels after main meal consumption
Periodo de tiempo: 2 hours
The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor.
2 hours
The mean amplitude of glycemic excursions (MAGE)
Periodo de tiempo: 24 hours
MAGE as parameter for the assessment of glycemic variability.
24 hours
Continuous overall net glycemic action (CONGA)
Periodo de tiempo: 1 hour, 2 hours, and 4 hours
CONGA to assess intraday glucose variability within predetermined time windows -> 1-hour interval (CONGA-1), 2-hour interval (CONGA-2), and 4-hour interval (CONGA-4).
1 hour, 2 hours, and 4 hours

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
High-Sensitivity C-Reactive Protein (hs-CRP) levels
Periodo de tiempo: Baseline, week 2, and twice in week 4
Fasting hs-CRP as inflammatory marker
Baseline, week 2, and twice in week 4
Blood pressure
Periodo de tiempo: Baseline, week 2, week 3, and twice in week 4
Office systolic and diastolic blood pressure
Baseline, week 2, week 3, and twice in week 4
Body weight
Periodo de tiempo: Baseline, week 2, week 3, and twice in week 4
Body weight in kilograms
Baseline, week 2, week 3, and twice in week 4
Height
Periodo de tiempo: Baseline, week 2, week 3, and twice in week 4
Height in centimeters
Baseline, week 2, week 3, and twice in week 4
Body Mass Index
Periodo de tiempo: Baseline, week 2, week 3, and twice in week 4
Body weight and height will be combined to report BMI in kg/m^2
Baseline, week 2, week 3, and twice in week 4
Waist circumference
Periodo de tiempo: Baseline, week 2, week 3, and twice in week 4
Waist circumference in centimeters
Baseline, week 2, week 3, and twice in week 4
Hip circumference
Periodo de tiempo: Baseline, week 2, week 3, and twice in week 4
Hip circumference in centimeters
Baseline, week 2, week 3, and twice in week 4
Waist to hip ratio
Periodo de tiempo: Baseline, week 2, week 3, and twice in week 4
Waist and hip circumference will be used to report the waist to hip ratio
Baseline, week 2, week 3, and twice in week 4

Colaboradores e Investigadores

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

Patrocinador

Maastricht University Medical Center

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)

14 de julio de 2021

Finalización primaria (Anticipado)

1 de diciembre de 2022

Finalización del estudio (Anticipado)

1 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

20 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2021

Publicado por primera vez (Actual)

20 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2022

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

25 de agosto de 2022

Última verificación

1 de agosto de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • METC 20-089

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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