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Completed

NCT Number: NCT04608136

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • weight stable > 3 months (changing < 5%)
  • 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
  • can consume food that provided in project
  • healthy

Exclusion criteria

  • 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
  • people who exercise vigorously (> 150 minutes per week)
  • 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
  • people who drink alcohol more than once a week
  • people who had a LDL level within 6 months > 190 mg/dl
  • fasting blood glucose levels > 250 mg/dl and using diabetes drugs other than metformin
  • people with heart disease, type 1 diabetes, renal impairment > level 3A
  • history of cancer, lung disease, gastrointestinal disease
  • people who smoke, people with eating disorder, people who have received psychiatric drugs
  • become a volunteer in a research project that is conducting a study related to food consumption
  • people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months
  • pregnancy or breastfeeding
  • egg allergy

Treatment and study plan

diet intervention

Behavioral

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

Primary outcomes

  1. Changes in weight following dietary intervention

    Time frame: Baseline and after 12 weeks

    weight (kg) analysis

  2. Changes in body mass index following dietary intervention

    Time frame: Baseline and after 12 weeks

    body mass index (kg/m^2) analysis

  3. Changes in waist circumference following dietary intervention

    Time frame: Baseline and after 12 weeks

    waist circumference (cm) analysis

  4. Changes in lipid profiles concentration following dietary intervention

    Time frame: Baseline and after 12 weeks

    Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-cholesterol (mg/dl) and LDL-cholesterol (mg/dl) concentration analysis

  5. Changes in blood glucose and insulin concentration following dietary intervention

    Time frame: Baseline and after 12 weeks

    HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis

  6. Changes in betahydroxybutirate concentration following dietary intervention

    Time frame: Baseline and after 12 weeks

    betahydroxybutirate (mmol/L) concentration analysis

  7. Changes in electrolytes concentration following dietary intervention

    Time frame: Baseline and after 12 weeks

    Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis

  8. Changes in physical activity

    Time frame: Baseline and after 12 weeks

    physical activity (MET-minutes/week) collect data by using questionnaires

  9. Change from baseline Glycemia at 180 minutes

    Time frame: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180

    glucose (mg/dl)

  10. Change from baseline Insulin at 180 minutes

    Time frame: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180

    insulin (μU/ml)

Secondary outcomes

  1. Changes in blood pressure

    Time frame: Baseline and after 12 weeks

    systolic and diastolic blood pressure (mmHg)

  2. Changes in fasting leptin levels

    Time frame: Baseline and after 12 weeks

    leptin (mg/dl) concentration analysis

  3. Changes in energy intake following dietary intervention

    Time frame: Baseline and after 12 weeks

    energy (kcal)

  4. Changes in carbohydrate following dietary intervention

    Time frame: Baseline and after 12 weeks

    carbohydrate (g)

  5. Changes in protein intake following dietary intervention

    Time frame: Baseline and after 12 weeks

    protein (g)

  6. Changes in fat intake following dietary intervention

    Time frame: Baseline and after 12 weeks

    fat (g)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • National Research Council of Thailand

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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