Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics in Individuals With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Diet intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yolk ketogenic diet<br>consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks | Behavioral: Diet intervention<br>* Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.<br>|
| Experimental: White ketogenic diet<br>consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks | Behavioral: Diet intervention<br>* Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.<br>|
| Active Comparator: Control group<br>decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level | Behavioral: Diet intervention<br>* Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight following dietary intervention | weight (kg) analysis | Baseline and after 12 weeks | 
| Changes in body mass index following dietary intervention | body mass index (kg/m^2) analysis | Baseline and after 12 weeks | 
| Changes in waist circumference following dietary intervention | waist circumference (cm) analysis | Baseline and after 12 weeks | 
| Changes in lipid profiles concentration following dietary intervention | 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 | HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis | Baseline and after 12 weeks | 
| Changes in betahydroxybutirate concentration following dietary intervention | betahydroxybutirate (mmol/L) concentration analysis | Baseline and after 12 weeks | 
| Changes in electrolytes concentration following dietary intervention | Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis | Baseline and after 12 weeks | 
| Changes in physical activity | physical activity (MET-minutes/week) collect data by using questionnaires | Baseline and after 12 weeks | 
| Change from baseline Glycemia at 180 minutes | glucose (mg/dl) | Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180 | 
| Change from baseline Insulin at 180 minutes | insulin (μU/ml) | Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure | systolic and diastolic blood pressure (mmHg) | Baseline and after 12 weeks | 
| Changes in fasting leptin levels | leptin (mg/dl) concentration analysis | Baseline and after 12 weeks | 
| Changes in energy intake following dietary intervention | energy (kcal) | Baseline and after 12 weeks | 
| Changes in carbohydrate following dietary intervention | carbohydrate (g) | Baseline and after 12 weeks | 
| Changes in protein intake following dietary intervention | protein (g) | Baseline and after 12 weeks | 
| Changes in fat intake following dietary intervention | fat (g) | Baseline and after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, diabetes, diet, eggs, cholesterol, weight loss