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

Mahidol University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Behavioral: Diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04608136

MU-CIRB 2019/255.0310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 3 patient groups

Yolk ketogenic diet

Experimental group

Description:

consume carbohydrate \< 10% and 3 whole eggs supplement per day in 12 weeks

Treatment:

Behavioral: Diet intervention

White ketogenic diet

Experimental group

Description:

consume carbohydrate \< 10% and 6 white eggs supplement per day in 12 weeks

Treatment:

Behavioral: Diet intervention

Control group

Active Comparator group

Description:

decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level

Treatment:

Behavioral: Diet intervention