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Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora

21 de septiembre de 2021 actualizado por: Yanna Zhu, Sun Yat-sen University

Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial

The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

In recent decades, unhealthy dietary patterns and insufficiency of physical activity have brought negative effects on human health, such as rapid increasing incidence of obesity, metabolic cardiovascular diseases, and mental disorders. The first line of prevention and therapy for these diseases is proper diet and lifestyle interventions. A series of studies conducted in vivo and vitro have shown that high-fiber diets and time-restricted eating present benefits in weight loss, reducing cardiovascular disease risk, and improving cognitive function. While, there is also a randomized controlled trial do not observe the effects of time-restricted eating on weight loss and decrease of metabolic risks. Meanwhile, few studies have examined the effects of high-fiber diets or time-restricted eating on executive function. Additionally, previous studies on high-fiber diets and time-restricted eating focused on middle-aged or elderly populations with some features of metabolic syndrome, while the effects on healthy young populations are unclear. More importantly, there are a small amount of studies exploring the combined effects of time-restricted eating and physical activity on metabolism and cognitive function. Therefore, our study is to estimate the effects of diet (high-fiber diets and time-restricted eating) and exercise (rope-skipping) interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

200

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

  • Porcelana
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510080
        • Reclutamiento
        • Department of Maternal and Child Health and Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yatsen University
        • 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

17 años a 24 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • First and second year undergraduate students in Sun Yat-sen University.
  • BMI≥22 kg/m^2.
  • Keeping weight stable for 3 months prior to study start (weight fluctuation <5kg).
  • Having the time and volunteering to receive the interventions.

Exclusion Criteria:

  • Currently engaged in other weight-loss studies.
  • With high blood pressure, diabetes or other cardiovascular diseases.
  • With secondary obesity induced by medicine or other diseases.
  • Contraindication to exercise.

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 paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
Conductual: Ejercicio
Ejercicio de saltar la cuerda tres veces por semana (90 minutos cada vez, y hay un descanso de 10 minutos después de 20 minutos de saltar la cuerda). Se usaría una pulsera de ejercicio y una pulsera inteligente para registrar el consumo de energía a lo largo del estudio.
Experimental: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
Conductual: Diet

Diet interventions include ten-hour time-restricted eating and a high-fiber diet.

  1. Participants will be instructed to take food from 7:30 AM until 5:30 PM and completely abstain from caloric intake for the remainder of the day (14 hours fast:10 hours eat). Only noncaloric beverages were permitted outside of the eating widow.
  2. According to the dietary recommendation proposed by Chinese Government and the existing dishes in the canteen , participants are instructed to eat following a high-diet recipe weekly from Monday to Friday which includes whole grain wheat rice, vegetables, fruits, and other foods rich in dietary fiber .
Experimental: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
Conductual: Ejercicio
Ejercicio de saltar la cuerda tres veces por semana (90 minutos cada vez, y hay un descanso de 10 minutos después de 20 minutos de saltar la cuerda). Se usaría una pulsera de ejercicio y una pulsera inteligente para registrar el consumo de energía a lo largo del estudio.
Conductual: Diet

Diet interventions include ten-hour time-restricted eating and a high-fiber diet.

  1. Participants will be instructed to take food from 7:30 AM until 5:30 PM and completely abstain from caloric intake for the remainder of the day (14 hours fast:10 hours eat). Only noncaloric beverages were permitted outside of the eating widow.
  2. According to the dietary recommendation proposed by Chinese Government and the existing dishes in the canteen , participants are instructed to eat following a high-diet recipe weekly from Monday to Friday which includes whole grain wheat rice, vegetables, fruits, and other foods rich in dietary fiber .
Sin intervención: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body weight
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Body weight change of participants
Baseline (1-2 days before the intervention), right after intervention (12 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body fat percentage
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Body fat percentage were measured by body composition analyzers.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fat mass
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fat mass (in kg) were measured by body composition analyzers.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Systolic and diastolic blood pressure
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Sitting systolic and diastolic blood pressure were measured with a validated electronic blood pressure monitor (model OMRON,HEM-7124).
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Serum lipid levels
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma glucose
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma glucose were analyzed by the glucose oxidase method.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma insulin
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma glucose were analyzed by the electrochemiluminescence method.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Intestinal flora
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
To measure the change of intestinal flora by analyzing feces genome 16S rDNA.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The executive functions were measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report Form. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Change in appetite sensations
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The appetite sensations were measured by the visual analogue scale (VAS).The VAS consisted of 100-mm lines and participants were required to place a vertical mark across the line corresponding best to their feelings of hunger, satisfaction, and fullness, with the scale ranging from 0 (not at all) to 100 (extremely). Quantification was performed by measuring the distance between the left end of the line and the vertical mark.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
High-Sensitivity C-Reactive Protein (hs-CRP)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum hs-CRP were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Intercellular adhesion molecule-1 (ICAM-1)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum ICAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Tumor necrosis factor alpha (TNF-alpha)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum TNF-alpha were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Chemokine CCL2
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum chemokine CCL2 were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Vascular cell adhesion molecule (VCAM-1)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum VCAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Interleukin-6 (IL-6)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum IL-6 were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Interleukin-8 (IL-8)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the IL-8 were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Leptin
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum leptin were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Tau protein
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum tau protein were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Brain-derived neurotrophic factor (BDNF)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum BDNF were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Vascular endothelial growth factor (VEGF)
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum VEGF were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Circulating metabolome
Periodo de tiempo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
To measure the change of circulating metabolome by LC-MS/MS method.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)

Colaboradores e Investigadores

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

Patrocinador

Sun Yat-sen University

Investigadores

  • Investigador principal: Yanna Zhu, M.D, Sun Yat-sen University

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)

2 de abril de 2021

Finalización primaria (Anticipado)

31 de diciembre de 2022

Finalización del estudio (Anticipado)

28 de febrero de 2023

Fechas de registro del estudio

Enviado por primera vez

3 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

6 de abril de 2021

Publicado por primera vez (Actual)

8 de abril de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2021

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

21 de septiembre de 2021

Última verificación

1 de septiembre de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • ZDGW[2021]044

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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