Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome
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Линкът е запазен в клипборда
СъстояниеНабиране
Спонсори
First Affiliated Hospital Xi'an Jiaotong University
Сътрудници
The Hospital for Sick Children
Leiden University
КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT04475822
BioSeek: nct04475822
Ключови думи
Резюме
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.
Дати
| Последна проверка: | 05/31/2020 |
| Първо изпратено: | 07/14/2020 |
| Очаквано записване подадено: | 07/14/2020 |
| Първо публикувано: | 07/16/2020 |
| Изпратена последна актуализация: | 07/14/2020 |
| Последна актуализация публикувана: | 07/16/2020 |
| Действителна начална дата на проучването: | 07/11/2020 |
| Приблизителна дата на първично завършване: | 12/30/2020 |
| Очаквана дата на завършване на проучването: | 10/30/2021 |
Състояние или заболяване
Metabolic Syndrome
Интервенция / лечение
Behavioral: Intermittent fasting
Behavioral: Low carb diet
Behavioral: Low carbon diet and intermittent fasting group
Фаза
-
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Intermittent fasting 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. | Behavioral: Intermittent fasting Intermittent fasting group: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. |
| Experimental: Low carb diet 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. | Behavioral: Low carb diet Low carb diet: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. |
| Experimental: Low carbon diet and intermittent fasting group Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group. | Behavioral: Low carbon diet and intermittent fasting group Low carbon diet and intermittent fasting group:Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - BMI：25--39.9kg/m2 - Satisfy any 3 or more of the following 5 points: - Waistline:male≥90cm female≥80cm - Triglyceride(TG)>150mg/dL（1.7mmol/L） - High-density lipoprotein(HDL-c)：male<40 mg/dL（1.03 mmol/L),female<50 mg/dL（1.29 mmol/L） - Fasting blood-glucose(FPG)≥100mg/dL（5.6mmol/L） - Blood pressure(BP)≥130/ 85mmHg Exclusion Criteria: - Body weight fluctuates by more than 4kg in the last 3 months - Pregnant or lactating women - Circadian rhythm disorders, such as shift workers - Suffering from malignant tumor, infection, chronic obstructive pulmonary disease, coronary heart disease and other major chronic diseases |
Резултат
Първични изходни мерки
1. weight [Three months after the intervention]
kg
2. body fat [Three months after the intervention]
Вторични изходни мерки
1. blood pressure [Three months after the intervention]
mmHg
2. blood glucose [Three months after the intervention]
mmol/L
