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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yolk ketogenic diet

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

Group Type EXPERIMENTAL

Diet intervention

Intervention Type BEHAVIORAL

Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

White ketogenic diet

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

Group Type EXPERIMENTAL

Diet intervention

Intervention Type BEHAVIORAL

Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

Control group

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

Group Type ACTIVE_COMPARATOR

Diet intervention

Intervention Type BEHAVIORAL

Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

Interventions

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Diet intervention

Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes