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

NCT04608136 | Completed

• 1 other identifier: MU-CIRB 2019/255.0310
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; diabetes; diet; eggs; cholesterol; weight loss

Outcome Measures

Primary Outcomes (10)

• Changes in weight following dietary intervention

  weight (kg) analysis

  Baseline and after 12 weeks

• Changes in body mass index following dietary intervention

  body mass index (kg/m\^2) analysis

  Baseline and after 12 weeks

• Changes in waist circumference following dietary intervention

  waist circumference (cm) analysis

  Baseline and after 12 weeks

• Changes in lipid profiles concentration following dietary intervention

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

  Baseline and after 12 weeks

• Changes in blood glucose and insulin concentration following dietary intervention

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

  Baseline and after 12 weeks

• Changes in betahydroxybutirate concentration following dietary intervention

  betahydroxybutirate (mmol/L) concentration analysis

  Baseline and after 12 weeks

• Changes in electrolytes concentration following dietary intervention

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

  Baseline and after 12 weeks

• Changes in physical activity

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

  Baseline and after 12 weeks

• Change from baseline Glycemia at 180 minutes

  glucose (mg/dl)

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

• Change from baseline Insulin at 180 minutes

  insulin (μU/ml)

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

Secondary Outcomes (6)

• Changes in blood pressure

  Baseline and after 12 weeks

• Changes in fasting leptin levels

  Baseline and after 12 weeks

• Changes in energy intake following dietary intervention

  Baseline and after 12 weeks

• Changes in carbohydrate following dietary intervention

  Baseline and after 12 weeks

• Changes in protein intake following dietary intervention

  Baseline and after 12 weeks

Study Arms (3)

Yolk ketogenic diet

EXPERIMENTAL

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

Behavioral: Diet intervention

White ketogenic diet

EXPERIMENTAL

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

Behavioral: Diet intervention

Control group

ACTIVE COMPARATOR

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

Behavioral: Diet intervention

Interventions

Diet intervention BEHAVIORAL

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

Control group; White ketogenic diet; Yolk ketogenic diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

• Pinsawas B, Surawit A, Mongkolsucharitkul P, Pongkunakorn T, Suta S, Manosan T, Ophakas S, Pumeiam S, Sranacharoenpong K, Mayurasakorn K. Asian Low-Carbohydrate Diet with Increased Whole Egg Consumption Improves Metabolic Outcomes in Metabolic Syndrome: A 52-Week Intervention Study. J Nutr. 2024 Nov;154(11):3331-3345. doi: 10.1016/j.tjnut.2024.08.027. Epub 2024 Sep 7.

  PMID: 39245182 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Weight Loss

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Korapat Mayurasakorn, MD.

  Doctor in Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 29, 2020
• Study Start: September 21, 2020
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-04

Locations

TH (1)