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

7. april 2022 opdateret af: Mahidol University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Yolk ketogenic diet
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
Adfærdsmæssigt: Diet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Eksperimentel: White ketogenic diet
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
Adfærdsmæssigt: Diet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Aktiv komparator: Control group
decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
Adfærdsmæssigt: Diet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in weight following dietary intervention
Tidsramme: Baseline and after 12 weeks
weight (kg) analysis
Baseline and after 12 weeks
Changes in body mass index following dietary intervention
Tidsramme: Baseline and after 12 weeks
body mass index (kg/m^2) analysis
Baseline and after 12 weeks
Changes in waist circumference following dietary intervention
Tidsramme: Baseline and after 12 weeks
waist circumference (cm) analysis
Baseline and after 12 weeks
Changes in lipid profiles concentration following dietary intervention
Tidsramme: Baseline and after 12 weeks
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
Tidsramme: Baseline and after 12 weeks
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
Baseline and after 12 weeks
Changes in betahydroxybutirate concentration following dietary intervention
Tidsramme: Baseline and after 12 weeks
betahydroxybutirate (mmol/L) concentration analysis
Baseline and after 12 weeks
Changes in electrolytes concentration following dietary intervention
Tidsramme: Baseline and after 12 weeks
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
Baseline and after 12 weeks
Changes in physical activity
Tidsramme: Baseline and after 12 weeks
physical activity (MET-minutes/week) collect data by using questionnaires
Baseline and after 12 weeks
Change from baseline Glycemia at 180 minutes
Tidsramme: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
glucose (mg/dl)
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
Change from baseline Insulin at 180 minutes
Tidsramme: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
insulin (μU/ml)
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in blood pressure
Tidsramme: Baseline and after 12 weeks
systolic and diastolic blood pressure (mmHg)
Baseline and after 12 weeks
Changes in fasting leptin levels
Tidsramme: Baseline and after 12 weeks
leptin (mg/dl) concentration analysis
Baseline and after 12 weeks
Changes in energy intake following dietary intervention
Tidsramme: Baseline and after 12 weeks
energy (kcal)
Baseline and after 12 weeks
Changes in carbohydrate following dietary intervention
Tidsramme: Baseline and after 12 weeks
carbohydrate (g)
Baseline and after 12 weeks
Changes in protein intake following dietary intervention
Tidsramme: Baseline and after 12 weeks
protein (g)
Baseline and after 12 weeks
Changes in fat intake following dietary intervention
Tidsramme: Baseline and after 12 weeks
fat (g)
Baseline and after 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mahidol University

Samarbejdspartnere

National Research Council of Thailand

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. september 2020

Primær færdiggørelse (Faktiske)

31. maj 2021

Studieafslutning (Faktiske)

31. december 2021

Datoer for studieregistrering

Først indsendt

21. september 2020

Først indsendt, der opfyldte QC-kriterier

28. oktober 2020

Først opslået (Faktiske)

29. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MU-CIRB 2019/255.0310

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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