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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Diet intervention

• Registration Number: NCT04608136
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Primary Completion: 2021-05-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. weight stable > 3 months (changing < 5%)
2. 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
3. can consume food that provided in project
4. healthy

Exclusion Criteria

1. 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
2. people who exercise vigorously (> 150 minutes per week)
3. 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
4. people who drink alcohol more than once a week
5. people who had a LDL level within 6 months > 190 mg/dl
6. fasting blood glucose levels > 250 mg/dl and using diabetes drugs other than metformin
7. people with heart disease, type 1 diabetes, renal impairment > level 3A
8. history of cancer, lung disease, gastrointestinal disease
9. people who smoke, people with eating disorder, people who have received psychiatric drugs
10. become a volunteer in a research project that is conducting a study related to food consumption
11. people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months
12. pregnancy or breastfeeding
13. egg allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White ketogenic diet	Diet intervention	consume carbohydrate \< 10% and 6 white eggs supplement per day in 12 weeks
Yolk ketogenic diet	Diet intervention	consume carbohydrate \< 10% and 3 whole eggs supplement per day in 12 weeks
Control group	Diet intervention	decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand