Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome
2022年4月7日 更新者：Mahidol University
Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics in Individuals With Metabolic Syndrome
This research compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of CVD in obese people.
研究概览
详细说明
This research study examines the effects of changes in weight, metabolism of glucose and cholesterol in the blood through diet and behavior modification.
The main objective of this study was to compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of CVD in obese people.
In addition, HDL quantity and size as well as HDL function was compared between the group who ate the whole egg and the group who did not eat the yolk.
研究类型
介入性
注册 (实际的)
76
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Bangkok
-
Bangkok Noi、Bangkok、泰国、10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- weight stable > 3 months (changing < 5%)
- three or more of the following five criteria are met 2.1 waist circumference ≥ 90 cm (men) or ≥ 80 cm (women) 2.2 fasting blood sugar ≥ 100 mg/dl 2.3 fasting triglyceride (TG) level ≥ 150 mg/dl 2.4 fasting high-density lipoprotein (HDL) cholesterol level ≤ 40 mg/dl (men) or ≤ 50 mg/dl (women) 2.5 blood pressure over 130/85 mmHg
- can consume food that provided in project
- healthy
Exclusion Criteria:
- consume drugs i.e. weight loss drugs, herbal pills, asthma drugs, steroid drugs, thyroid drugs, insulin injections, SGLT1 inhibitors drugs, SGLT2 inhibitors drugs, sulfonylurea drugs, blood lipid-lowering drugs
- people who exercise vigorously (> 150 minutes per week)
- people who are or have weight loss by consuming less than 30% of carbohydrates, or are losing weight by other methods or who have eaten a specific diet as prescribed by a doctor within the past 6 months
- people who drink alcohol more than once a week
- people who had a LDL level within 6 months > 190 mg/dl
- fasting blood glucose levels > 250 mg/dl and using diabetes drugs other than metformin
- people with heart disease, type 1 diabetes, renal impairment > level 3A
- history of cancer, lung disease, gastrointestinal disease
- people who smoke, people with eating disorder, people who have received psychiatric drugs
- become a volunteer in a research project that is conducting a study related to food consumption
- people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months
- pregnancy or breastfeeding
- egg allergy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Yolk ketogenic diet
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
|
实验性的：White ketogenic diet
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
|
有源比较器：Control group
decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in weight following dietary intervention
大体时间：Baseline and after 12 weeks
|
weight (kg) analysis
|
Baseline and after 12 weeks
|
|
Changes in body mass index following dietary intervention
大体时间：Baseline and after 12 weeks
|
body mass index (kg/m^2) analysis
|
Baseline and after 12 weeks
|
|
Changes in waist circumference following dietary intervention
大体时间：Baseline and after 12 weeks
|
waist circumference (cm) analysis
|
Baseline and after 12 weeks
|
|
Changes in lipid profiles concentration following dietary intervention
大体时间：Baseline and after 12 weeks
|
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-cholesterol (mg/dl) and LDL-cholesterol (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in blood glucose and insulin concentration following dietary intervention
大体时间：Baseline and after 12 weeks
|
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in betahydroxybutirate concentration following dietary intervention
大体时间：Baseline and after 12 weeks
|
betahydroxybutirate (mmol/L) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in electrolytes concentration following dietary intervention
大体时间：Baseline and after 12 weeks
|
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in physical activity
大体时间：Baseline and after 12 weeks
|
physical activity (MET-minutes/week) collect data by using questionnaires
|
Baseline and after 12 weeks
|
|
Change from baseline Glycemia at 180 minutes
大体时间：Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
glucose (mg/dl)
|
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
|
Change from baseline Insulin at 180 minutes
大体时间：Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
insulin (μU/ml)
|
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in blood pressure
大体时间：Baseline and after 12 weeks
|
systolic and diastolic blood pressure (mmHg)
|
Baseline and after 12 weeks
|
|
Changes in fasting leptin levels
大体时间：Baseline and after 12 weeks
|
leptin (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in energy intake following dietary intervention
大体时间：Baseline and after 12 weeks
|
energy (kcal)
|
Baseline and after 12 weeks
|
|
Changes in carbohydrate following dietary intervention
大体时间：Baseline and after 12 weeks
|
carbohydrate (g)
|
Baseline and after 12 weeks
|
|
Changes in protein intake following dietary intervention
大体时间：Baseline and after 12 weeks
|
protein (g)
|
Baseline and after 12 weeks
|
|
Changes in fat intake following dietary intervention
大体时间：Baseline and after 12 weeks
|
fat (g)
|
Baseline and after 12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年9月21日
初级完成 (实际的)
2021年5月31日
研究完成 (实际的)
2021年12月31日
研究注册日期
首次提交
2020年9月21日
首先提交符合 QC 标准的
2020年10月28日
首次发布 (实际的)
2020年10月29日
研究记录更新
最后更新发布 (实际的)
2022年4月8日
上次提交的符合 QC 标准的更新
2022年4月7日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.