Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics in Individuals With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Changes in electrolytes concentration following dietary intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in electrolytes concentration following dietary intervention
时间窗: Baseline and after 12 weeks
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
Changes in physical activity
时间窗: Baseline and after 12 weeks
physical activity (MET-minutes/week) collect data by using questionnaires
Changes in betahydroxybutirate concentration following dietary intervention
时间窗: Baseline and after 12 weeks
betahydroxybutirate (mmol/L) concentration analysis
Change from baseline Glycemia at 180 minutes
时间窗: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
glucose (mg/dl)
Changes in weight following dietary intervention
时间窗: Baseline and after 12 weeks
weight (kg) analysis
Changes in lipid profiles concentration following dietary intervention
时间窗: Baseline and after 12 weeks
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-cholesterol (mg/dl) and LDL-cholesterol (mg/dl) concentration analysis
Changes in blood glucose and insulin concentration following dietary intervention
时间窗: Baseline and after 12 weeks
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
Changes in body mass index following dietary intervention
时间窗: Baseline and after 12 weeks
body mass index (kg/m\^2) analysis
Changes in waist circumference following dietary intervention
时间窗: Baseline and after 12 weeks
waist circumference (cm) analysis
Change from baseline Insulin at 180 minutes
时间窗: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
insulin (μU/ml)
次要结局
- Changes in carbohydrate following dietary intervention(Baseline and after 12 weeks)
- Changes in fat intake following dietary intervention(Baseline and after 12 weeks)
- Changes in energy intake following dietary intervention(Baseline and after 12 weeks)
- Changes in protein intake following dietary intervention(Baseline and after 12 weeks)
- Changes in blood pressure(Baseline and after 12 weeks)
- Changes in fasting leptin levels(Baseline and after 12 weeks)