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Metabolic SyndromeNCT04608136

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

A study testing Diet intervention in people with Metabolic Syndrome, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome
What is being tested?
Diet intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteThailand
Study dates
21 Sep 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics 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.

Read the 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.

Being tested
Diet intervention
Keywords
metabolic syndrome, diabetes, diet, eggs, cholesterol, weight loss
Medical subject headings
Metabolic Syndrome, Diabetes Mellitus, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet interventionBehavioural

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

Study groups in NCT04608136
Study groupRoleWhat they receive
Yolk ketogenic dietExperimentalconsume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
Receives: Behavioral: Diet intervention
White ketogenic dietExperimentalconsume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
Receives: Behavioral: Diet intervention
Control groupActive comparatordecrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
Receives: Behavioral: Diet intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in weight following dietary intervention

    weight (kg) analysis

    Measured: Baseline and after 12 weeks

  2. Changes in body mass index following dietary intervention

    body mass index (kg/m^2) analysis

    Measured: Baseline and after 12 weeks

  3. Changes in waist circumference following dietary intervention

    waist circumference (cm) analysis

    Measured: Baseline and after 12 weeks

  4. 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

    Measured: Baseline and after 12 weeks

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

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

    Measured: Baseline and after 12 weeks

  6. Changes in betahydroxybutirate concentration following dietary intervention

    betahydroxybutirate (mmol/L) concentration analysis

    Measured: Baseline and after 12 weeks

  7. Changes in electrolytes concentration following dietary intervention

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

    Measured: Baseline and after 12 weeks

  8. Changes in physical activity

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

    Measured: Baseline and after 12 weeks

  9. Change from baseline Glycemia at 180 minutes

    glucose (mg/dl)

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

  10. Change from baseline Insulin at 180 minutes

    insulin (μU/ml)

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

Secondary outcomes (6)

  1. Changes in blood pressure

    systolic and diastolic blood pressure (mmHg)

    Measured: Baseline and after 12 weeks

  2. Changes in fasting leptin levels

    leptin (mg/dl) concentration analysis

    Measured: Baseline and after 12 weeks

  3. Changes in energy intake following dietary intervention

    energy (kcal)

    Measured: Baseline and after 12 weeks

  4. Changes in carbohydrate following dietary intervention

    carbohydrate (g)

    Measured: Baseline and after 12 weeks

  5. Changes in protein intake following dietary intervention

    protein (g)

    Measured: Baseline and after 12 weeks

  6. Changes in fat intake following dietary intervention

    fat (g)

    Measured: Baseline and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start21 Sep 2020
  3. Primary completion31 May 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04608136
Sponsor's protocol ID
MU-CIRB 2019/255.0310
Status last verified
Apr 2022
First submitted
21 Sep 2020
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39245182

Questions about this trial

What is this clinical trial studying?

A study testing Diet intervention in people with Metabolic Syndrome, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in weight following dietary intervention (time frame: Baseline and after 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04608136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

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