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

7 april 2022 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

76

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Yolk ketogenic diet
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Experimentell: White ketogenic diet
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
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
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in weight following dietary intervention
Tidsram: Baseline and after 12 weeks
weight (kg) analysis
Baseline and after 12 weeks
Changes in body mass index following dietary intervention
Tidsram: Baseline and after 12 weeks
body mass index (kg/m^2) analysis
Baseline and after 12 weeks
Changes in waist circumference following dietary intervention
Tidsram: Baseline and after 12 weeks
waist circumference (cm) analysis
Baseline and after 12 weeks
Changes in lipid profiles concentration following dietary intervention
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and after 12 weeks
betahydroxybutirate (mmol/L) concentration analysis
Baseline and after 12 weeks
Changes in electrolytes concentration following dietary intervention
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 september 2020

Primärt slutförande (Faktisk)

31 maj 2021

Avslutad studie (Faktisk)

31 december 2021

Studieregistreringsdatum

Först inskickad

21 september 2020

Först inskickad som uppfyllde QC-kriterierna

28 oktober 2020

Första postat (Faktisk)

29 oktober 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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