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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Diet intervention

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: National Research Council of Thailand

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: diabetes; weight loss; diet; metabolic syndrome; cholesterol; eggs
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: MU-CIRB 2019/255.0310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No