Completado

An Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Intermittent fasting

+ Low carb diet

+ Low carbon diet and intermittent fasting group

Conductual
Quiénes están siendo reclutados

Hiperinsulinismo+1

+ Resistencia a la Insulina

+ Enfermedades metabólicas

De 18 a 65 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: julio de 2020
Ver detalles del protocolo

Resumen

Patrocinador PrincipalFirst Affiliated Hospital Xi'an Jiaotong University
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 12 de julio de 2020

Fecha en la que se inscribió al primer participante.

The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. It is a common problem facing public health and clinical practice.Metabolic syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and obesity (especially central obesity).Researchers believe that the common pathological basis of these manifestations is insulin resistance, which is generally considered to be a reduction in the biological effects of insulin compared with the normal biological effects of expected biological phenomena.Nowadays, there are more and more studies on insulin resistance in the world. We have known that age, poor living and eating habits, high blood fat, high blood sugar and stress all lead to insulin resistance. The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the incidence of chronic diseases in patients with metabolic syndrome through the intervention of lifestyle and diet habits in the early stage of the disease.

Título OficialAn Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome
NCT04475822
Patrocinador PrincipalFirst Affiliated Hospital Xi'an Jiaotong University
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 169 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 65 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

HiperinsulinismoResistencia a la InsulinaEnfermedades metabólicasEnfermedades Nutricionales y Metabólicas

Criterios

Inclusion criteria 1. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5): 1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women). 2. Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L). 3. Reduced HDL-c (use of medications for reduced HDL-c is an alternate indicator) \< 40 mg/dL (1.0 mmol/L) in males \< 50 mg/dL (1.3 mmol/L) in females. 4. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg. 5. Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L). 2. Age from 18 to 65 years. 3. Stable weight (change ≤ 10% current body weight) for 3 months prior to the study. 4. If participates were on hypoglycemic medications, hypotensive medications, lipid-lowering medications and cardiovascular medications, dose adjustment was not permitted during the 3-month intervention. Exclusion criteria 1. Pregnant or breast-feeding. 2. Night shift workers. 3. History of major diseases or related diseases, such as inflammatory disease, rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis, chronic kidney disease, acquired immunodeficiency syndrome, eating disorder, uncontrolled psychiatric disorder and major adverse cardiovascular event. 4. Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite. 5. History of weight-loss surgery.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

3 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.

Grupo II

Experimental
According to the definition of low carbon diet given by R. D. Feinman et al. (Nutrition, 2015), the daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.

Grupo III

Experimental
Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

First Affiliated Hospital of Xi an Jiaotong University

Xi'an, ChinaAbrir First Affiliated Hospital of Xi an Jiaotong University en Google Maps
Completado1 Centros de Estudio