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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mai 2019

Primær fullføring (Faktiske)

20. april 2020

Studiet fullført (Faktiske)

20. april 2020

Datoer for studieregistrering

Først innsendt

3. september 2020

Først innsendt som oppfylte QC-kriteriene

5. oktober 2020

Først lagt ut (Faktiske)

12. oktober 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Oil4Egg

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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