Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, diabetes, diet, eggs, cholesterol, weight loss
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.
Interventions
BEHAVIORALDiet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Sponsors
National Research Council of Thailand
Mahidol University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Insulin at 180 minutes | Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180 | insulin (μU/ml) |
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Changes in blood pressure | Baseline and after 12 weeks | systolic and diastolic blood pressure (mmHg) |
Countries
Thailand
Outcome results
None listed