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

5. října 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

24

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

35 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: 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
Experimentální: 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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Glycated haemoglobin (HbA1c)
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Glucose
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Activated clotting time (ACT)
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Iron
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Transferrin
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Ferritin
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
% transferrin saturation
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Vitamin B12
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
25-hydroxy-vitamin D
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Protein
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Albumin
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
C-reactive protein (CRP)
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Interleukin-6
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Interleukin-1b
Časové okno: 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)
Časové okno: 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)
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Nitrosylated hemoglobin (HbNO)
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
blood samples
baseline (visit 1) and Day 90 (last visit 4)
Satiety
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
Tonometry
baseline (visit 1) and Day 90 (last visit 4)
Systolic blood pressure
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
Tensiometer
baseline (visit 1) and Day 90 (last visit 4)
Diastolic blood pressure
Časové okno: baseline (visit 1) and Day 90 (last visit 4)
Tensiometer
baseline (visit 1) and Day 90 (last visit 4)
Glycated haemoglobin (HbA1c)
Časové okno: Day 30 (visit 2) and Day 60 (visit 3)
Glycated haemoglobin in blood sample
Day 30 (visit 2) and Day 60 (visit 3)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Yvan Larondelle, Prof, Université Catholique de Louvain

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. května 2019

Primární dokončení (Aktuální)

20. dubna 2020

Dokončení studie (Aktuální)

20. dubna 2020

Termíny zápisu do studia

První předloženo

3. září 2020

První předloženo, které splnilo kritéria kontroly kvality

5. října 2020

První zveřejněno (Aktuální)

12. října 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. října 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. října 2020

Naposledy ověřeno

1. října 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • Oil4Egg

Plán pro data jednotlivých účastníků (IPD)

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NE

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