Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Diet intervention
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, diabetes, diet, eggs, cholesterol, weight loss
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Yolk ketogenic diet
White ketogenic diet
Control group
Arm Description
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
Outcomes
Primary Outcome Measures
Changes in weight following dietary intervention
weight (kg) analysis
Changes in body mass index following dietary intervention
body mass index (kg/m^2) analysis
Changes in waist circumference following dietary intervention
waist circumference (cm) analysis
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
Changes in blood glucose and insulin concentration following dietary intervention
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
Changes in betahydroxybutirate concentration following dietary intervention
betahydroxybutirate (mmol/L) concentration analysis
Changes in electrolytes concentration following dietary intervention
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
Changes in physical activity
physical activity (MET-minutes/week) collect data by using questionnaires
Change from baseline Glycemia at 180 minutes
glucose (mg/dl)
Change from baseline Insulin at 180 minutes
insulin (μU/ml)
Secondary Outcome Measures
Changes in blood pressure
systolic and diastolic blood pressure (mmHg)
Changes in fasting leptin levels
leptin (mg/dl) concentration analysis
Changes in energy intake following dietary intervention
energy (kcal)
Changes in carbohydrate following dietary intervention
carbohydrate (g)
Changes in protein intake following dietary intervention
protein (g)
Changes in fat intake following dietary intervention
fat (g)
Full Information
NCT ID
NCT04608136
First Posted
September 21, 2020
Last Updated
April 7, 2022
Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
1. Study Identification
Unique Protocol Identification Number
NCT04608136
Brief Title
Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome
Official Title
Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics in Individuals With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, diabetes, diet, eggs, cholesterol, weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yolk ketogenic diet
Arm Type
Experimental
Arm Description
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
Arm Title
White ketogenic diet
Arm Type
Experimental
Arm Description
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
Intervention Type
Behavioral
Intervention Name(s)
Diet intervention
Intervention Description
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Primary Outcome Measure Information:
Title
Changes in weight following dietary intervention
Description
weight (kg) analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in body mass index following dietary intervention
Description
body mass index (kg/m^2) analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in waist circumference following dietary intervention
Description
waist circumference (cm) analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in lipid profiles concentration following dietary intervention
Description
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-cholesterol (mg/dl) and LDL-cholesterol (mg/dl) concentration analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in blood glucose and insulin concentration following dietary intervention
Description
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in betahydroxybutirate concentration following dietary intervention
Description
betahydroxybutirate (mmol/L) concentration analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in electrolytes concentration following dietary intervention
Description
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in physical activity
Description
physical activity (MET-minutes/week) collect data by using questionnaires
Time Frame
Baseline and after 12 weeks
Title
Change from baseline Glycemia at 180 minutes
Description
glucose (mg/dl)
Time Frame
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
Title
Change from baseline Insulin at 180 minutes
Description
insulin (μU/ml)
Time Frame
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
Secondary Outcome Measure Information:
Title
Changes in blood pressure
Description
systolic and diastolic blood pressure (mmHg)
Time Frame
Baseline and after 12 weeks
Title
Changes in fasting leptin levels
Description
leptin (mg/dl) concentration analysis
Time Frame
Baseline and after 12 weeks
Title
Changes in energy intake following dietary intervention
Description
energy (kcal)
Time Frame
Baseline and after 12 weeks
Title
Changes in carbohydrate following dietary intervention
Description
carbohydrate (g)
Time Frame
Baseline and after 12 weeks
Title
Changes in protein intake following dietary intervention
Description
protein (g)
Time Frame
Baseline and after 12 weeks
Title
Changes in fat intake following dietary intervention
Description
fat (g)
Time Frame
Baseline and after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korapat Mayurasakorn, MD.
Organizational Affiliation
Doctor in Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
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Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome
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