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Intestinal Tolerance & Health Effects of Daily Consumption of Two Eggs With Fatty Acid Profile Related to Metabolic Disorders (Oil4Egg)

5 oktober 2020 bijgewerkt door: Université Catholique de Louvain

To Evaluate the Intestinal Tolerance and Health Effects of Daily Consumption of Two Eggs With a Particular Fatty Acid Profile on a Set of Parameters Related to Metabolic Disorders

This study has two objectives: 1) to check that the daily consumption of two eggs with a particular fatty acid pattern rich in n-3 polyunsaturated fatty acids (α-linolenic acid, docosahexaenoic acid), conjugated-linoleic acid and conjugated-linolenic acid is well tolerated by the consumer ; 2) to evaluate the effects of the consumption of these eggs on health parameters in subjects presenting a risk of developing a metabolic disorder.

This monocentric study is an interventional, randomized, double-blind, control study.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids show interesting effects in the context of health. Indeed, some studies suggest positive effects on circulating lipids or inflammation associated with certain disorders such as diabetes, following the consumption of these fatty acids.

However, these fatty acids are not very present in the classic diet. Therefore, we have developped hens eggs naturally enriched in n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids by changing the hens feed.

This study has two objectives: 1) to check that the daily consumption of two eggs with a particular fatty acid pattern rich in n-3 polyunsaturated fatty acids (α-linolenic acid, docosahexaenoic acid), conjugated-linoleic acid and conjugated-linolenic acid is well tolerated by the consumer ; 2) to evaluate the effects of the consumption of these eggs on health parameters in subjects presenting a risk of developing a metabolic disorder.

To do this, 80 subjects aged 35 to 75, sedentary (<2 hours of physical activity per week) and with abdominal obesity (> 94cm for men and> 80cm for women) were recruited and were divided into two groups: the control group (12 subjects consuming 2 classic eggs for 3 months per day) or the test group (12 subjects consuming 2 eggs enriched in omega per day for 3 months).

A medical examination with blood sampling was scheduled every month at baseline (Day 0), after one month (Day 30), after two months (Day 60) and at the end of the 3 months of intervention (Day90). During those visits, the following were monitored: glucose parameters, lipids parameters, fatty acid profile of red blood cells and plasma and safety parameters related to haematology, kidney and liver functions .

During these monthly medical visits patients also completed the questionnaires assessing intestinal tolerance (visual analogue scale showing 10 gastrointestinal symptoms), satiety (visual analog scale questionnaire) and well-being (36 items short form survey). Eating habits were monitored using a food diary. Additional parameters were measured only during the first and the last visit: coagulation, nutritional status, endothelial function and inflammation.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Louvain-La-Neuve, België, 1348
        • Center of Investigation in Clinical Nutrition

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

35 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Woman or man, aged of 35 to 75 years
  • Abdominal obesity : waist circumference for men > 94cm and > 80cm for women
  • Practicing < 2h of physical activity per week

Exclusion Criteria:

  • Uncontrolled systolic blood pressure > 160/100mmHg
  • For premenopausal women: pregnant or lactating women
  • For menopausal women: less than 6 months of menopause
  • Perimenopausal women with symptoms
  • Type II diabetes (fasted glycaemia ≥ 126mg/dl or HbA1c ≥ 6.5%), Type I diabetes
  • Medical history or actual cardiovascular disease (myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
  • Familial history of premature cardiovascular incident (in male first degree relative < 55 years and in female first degree relative < 65 years; myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
  • Medical history or actual liver, pancreas, kidney, pulmonary or gastrointestinal problem
  • Thyroid disorder
  • Cancer < 5 years before the screening visit
  • Smokers or who have stopped smoking within 6 months before the screening visit
  • Subject presenting allergy or food intolerance to eggs
  • Subjects with psychiatric problems and/or using antipsychotics
  • Drug addiction problem
  • Recent change of body weight > 5kg (< 3 months before the screening visit)
  • Within 3 months before the screening visit, change in the chronic (> 7 days in a row) intake or dosage of drug(s) or product(s) modifying

    • The glucose or lipid metabolism
    • The blood pressure and heart rate
    • Intestinal tolerance
    • Hepatic, pancreas or kidney functions
    • Satiety
    • The inflammatory status
  • Current or recent (< 3 months before the screening visit) intake of dietary supplements rich in n-3 polyunsaturated fatty acid
  • Vegan diet
  • Consumption of fish > 3 times per week
  • Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day)
  • LDL > 159 mg/dl or total cholesterol > 239 mg/dl or triglyceride > 200 mg/dl or HDL < 40 mg/dl
  • Docosahexaenoic acid in red blood cell phospholipids > 8 %
  • Subjects having participated to another clinical trial < 1 month before the screening test visit

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Control
Consumption of two "classical eggs" per day during three months. The fatty acid pattern of those eggs is characterized by: total saturated fatty acid 34.25%, total monounsaturated fatty acid 47.68%, total n-6 polyunsaturated fatty acid 16.97%, total n-3 polyunsaturated fatty acid 1.10%.
Consumption of two eggs (control or test) per day during three months
Experimenteel: Test
Consumption of two test eggs per day during three months. These eggs are naturally enriched in n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids (total saturated fatty acid 31.74%, total monounsaturated fatty acid 28.09%, total n-6 polyunsaturated fatty acid 16.07%, total n-3 polyunsaturated fatty acid 6.51%)
Consumption of two eggs (control or test) per day during three months

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glycated haemoglobin (HbA1c)
Tijdsspanne: Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)
Glycated haemoglobin (HbA1c) in blood samples
Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glucose
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Insulin
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Homeostatic model assessment (HOMA)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Quantitative insulin sensitivity check index (QUICKI)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Triglycerides
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Total cholesterol
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
low-density lipoprotein (LDL) cholesterol
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
high-density lipoprotein (HDL) cholesterol
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
non-high-density lipoprotein cholesterol (non-HDL)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Fatty acid pattern in red blood cells
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Fatty acid pattern plasma
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Urea
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Uric acid
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Creatinine
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Glomerular filtration rate (GFR)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Sodium (Na)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Potassium (K)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Chlore (Cl)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Phosphate (P)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Alanine transaminase (ALAT)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Aspartate aminotransferase (ASAT)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Gamma-glutamyl transferase (GGT)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Alkaline phosphatase (ALP)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Lipase
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Haemoglobin
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Mean corpuscular volume (MCV)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Mean corpuscular hemoglobin concentration (MCHC)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Red blood cells
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
White blood cells
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Blood cell count
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Reticulocytes
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Haematocrit
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Body weight
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Impedancemeter
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Waist circumference
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Measuring tape
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Hip circumference
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Measuring tape
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Fat mass
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Impedancemeter
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Lean mass
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Impedancemeter
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Visceral fat mass
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Impedancemeter
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
International normalized ratio (INR)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Activated clotting time (ACT)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Iron
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Transferrin
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Ferritin
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
% transferrin saturation
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Vitamin B12
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
25-hydroxy-vitamin D
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Protein
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Albumin
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
C-reactive protein (CRP)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Interleukin-6
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Interleukin-1b
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Tumor necrosis factor alpha (TNFa)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Oxidized low-density lipoprotein (LDLox)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Nitrosylated hemoglobin (HbNO)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Satiety
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
visual analog scale questionnaire
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Intestinal tolerance
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
visual analog scale questionnaire
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Quality of life 36-item short-form survey (SF36)
Tijdsspanne: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
SF36 questionnaire
baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Reactive hyperemia index (LnRHI)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
Tonometry
baseline (visit 1) and Day 90 (last visit 4)
Augmentation index normalized for heart rate (AI@75bpm)
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
Tonometry
baseline (visit 1) and Day 90 (last visit 4)
Systolic blood pressure
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
Tensiometer
baseline (visit 1) and Day 90 (last visit 4)
Diastolic blood pressure
Tijdsspanne: baseline (visit 1) and Day 90 (last visit 4)
Tensiometer
baseline (visit 1) and Day 90 (last visit 4)
Glycated haemoglobin (HbA1c)
Tijdsspanne: Day 30 (visit 2) and Day 60 (visit 3)
Glycated haemoglobin in blood sample
Day 30 (visit 2) and Day 60 (visit 3)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Yvan Larondelle, Prof, Université Catholique de Louvain

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 mei 2019

Primaire voltooiing (Werkelijk)

20 april 2020

Studie voltooiing (Werkelijk)

20 april 2020

Studieregistratiedata

Eerst ingediend

3 september 2020

Eerst ingediend dat voldeed aan de QC-criteria

5 oktober 2020

Eerst geplaatst (Werkelijk)

12 oktober 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 oktober 2020

Laatste update ingediend die voldeed aan QC-criteria

5 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Oil4Egg

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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