Clinical trial NCT04608136: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
diabetes
diet
eggs
cholesterol
weight loss
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2020-10-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in weight following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in body mass index following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in waist circumference following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in lipid profiles concentration following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in blood glucose and insulin concentration following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in betahydroxybutirate concentration following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in electrolytes concentration following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in physical activity
timeFrame: Baseline and after 12 weeks
measure: Change from baseline Glycemia at 180 minutes
timeFrame: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
measure: Change from baseline Insulin at 180 minutes
timeFrame: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: Baseline and after 12 weeks
measure: Changes in fasting leptin levels
timeFrame: Baseline and after 12 weeks
measure: Changes in energy intake following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in carbohydrate following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in protein intake following dietary intervention
timeFrame: Baseline and after 12 weeks
measure: Changes in fat intake following dietary intervention
timeFrame: Baseline and after 12 weeks
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Doctor in Family Medicine
name: Korapat Mayurasakorn, MD.
role: PRINCIPAL_INVESTIGATOR
References: