Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

5. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

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

35 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 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
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glycated haemoglobin (HbA1c)
Tidsramme: 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)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studieleder: Yvan Larondelle, Prof, Université Catholique de Louvain

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)

20. maj 2019

Primær færdiggørelse (Faktiske)

20. april 2020

Studieafslutning (Faktiske)

20. april 2020

Datoer for studieregistrering

Først indsendt

3. september 2020

Først indsendt, der opfyldte QC-kriterier

5. oktober 2020

Først opslået (Faktiske)

12. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Oil4Egg

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner