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

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04608136

Collaborator

National Research Council of Thailand (Other)

Enrollment

Location

Arms

15.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Behavioral: Diet intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 21, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in weight following dietary intervention [Baseline and after 12 weeks]
weight (kg) 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
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 betahydroxybutirate concentration following dietary intervention [Baseline and after 12 weeks]
betahydroxybutirate (mmol/L) concentration analysis
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
Change from baseline Glycemia at 180 minutes [Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180]
glucose (mg/dl)
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

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
Changes in energy intake following dietary intervention [Baseline and after 12 weeks]
energy (kcal)
Changes in carbohydrate following dietary intervention [Baseline and after 12 weeks]
carbohydrate (g)
Changes in protein intake following dietary intervention [Baseline and after 12 weeks]
protein (g)
Changes in fat intake following dietary intervention [Baseline and after 12 weeks]
fat (g)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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