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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608136
• Other study ID #: MU-CIRB 2019/255.0310
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Diet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight following dietary intervention	weight (kg) analysis	Baseline and after 12 weeks
Primary	Changes in body mass index following dietary intervention	body mass index (kg/m^2) analysis	Baseline and after 12 weeks
Primary	Changes in waist circumference following dietary intervention	waist circumference (cm) analysis	Baseline and after 12 weeks
Primary	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
Primary	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
Primary	Changes in betahydroxybutirate concentration following dietary intervention	betahydroxybutirate (mmol/L) concentration analysis	Baseline and after 12 weeks
Primary	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
Primary	Changes in physical activity	physical activity (MET-minutes/week) collect data by using questionnaires	Baseline and after 12 weeks
Primary	Change from baseline Glycemia at 180 minutes	glucose (mg/dl)	Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
Primary	Change from baseline Insulin at 180 minutes	insulin (µU/ml)	Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
Secondary	Changes in blood pressure	systolic and diastolic blood pressure (mmHg)	Baseline and after 12 weeks
Secondary	Changes in fasting leptin levels	leptin (mg/dl) concentration analysis	Baseline and after 12 weeks
Secondary	Changes in energy intake following dietary intervention	energy (kcal)	Baseline and after 12 weeks
Secondary	Changes in carbohydrate following dietary intervention	carbohydrate (g)	Baseline and after 12 weeks
Secondary	Changes in protein intake following dietary intervention	protein (g)	Baseline and after 12 weeks
Secondary	Changes in fat intake following dietary intervention	fat (g)	Baseline and after 12 weeks