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Completed

NCT Number: NCT04583657

Intestinal Tolerance & Health Effects of Daily Consumption of Two Eggs With Fatty Acid Profile 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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, 1348, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eggs

Other

Consumption of two eggs (control or test) per day during three months

Primary outcomes

  1. Glycated haemoglobin (HbA1c)

    Time frame: Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)

    Glycated haemoglobin (HbA1c) in blood samples

Secondary outcomes

  1. Glucose

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  2. Insulin

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  3. Homeostatic model assessment (HOMA)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  4. Quantitative insulin sensitivity check index (QUICKI)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  5. Triglycerides

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  6. Total cholesterol

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  7. low-density lipoprotein (LDL) cholesterol

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  8. high-density lipoprotein (HDL) cholesterol

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  9. non-high-density lipoprotein cholesterol (non-HDL)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  10. Fatty acid pattern in red blood cells

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  11. Fatty acid pattern plasma

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  12. Urea

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  13. Uric acid

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  14. Creatinine

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  15. Glomerular filtration rate (GFR)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  16. Sodium (Na)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  17. Potassium (K)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  18. Chlore (Cl)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  19. Phosphate (P)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  20. Alanine transaminase (ALAT)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  21. Aspartate aminotransferase (ASAT)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  22. Gamma-glutamyl transferase (GGT)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  23. Alkaline phosphatase (ALP)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  24. Lipase

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  25. Haemoglobin

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  26. Mean corpuscular volume (MCV)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  27. Mean corpuscular hemoglobin concentration (MCHC)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  28. Red blood cells

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  29. White blood cells

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  30. Blood cell count

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  31. Reticulocytes

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  32. Haematocrit

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    blood samples

  33. Body weight

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    Impedancemeter

  34. Waist circumference

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    Measuring tape

  35. Hip circumference

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    Measuring tape

  36. Fat mass

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    Impedancemeter

  37. Lean mass

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    Impedancemeter

  38. Visceral fat mass

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    Impedancemeter

  39. International normalized ratio (INR)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  40. Activated clotting time (ACT)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  41. Iron

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  42. Transferrin

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  43. Ferritin

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  44. % transferrin saturation

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  45. Vitamin B12

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  46. 25-hydroxy-vitamin D

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  47. Protein

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  48. Albumin

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  49. C-reactive protein (CRP)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  50. Interleukin-6

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  51. Interleukin-1b

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  52. Tumor necrosis factor alpha (TNFa)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  53. Oxidized low-density lipoprotein (LDLox)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  54. Nitrosylated hemoglobin (HbNO)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    blood samples

  55. Satiety

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    visual analog scale questionnaire

  56. Intestinal tolerance

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    visual analog scale questionnaire

  57. Quality of life 36-item short-form survey (SF36)

    Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

    SF36 questionnaire

  58. Reactive hyperemia index (LnRHI)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    Tonometry

  59. Augmentation index normalized for heart rate (AI@75bpm)

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    Tonometry

  60. Systolic blood pressure

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    Tensiometer

  61. Diastolic blood pressure

    Time frame: baseline (visit 1) and Day 90 (last visit 4)

    Tensiometer

  62. Glycated haemoglobin (HbA1c)

    Time frame: Day 30 (visit 2) and Day 60 (visit 3)

    Glycated haemoglobin in blood sample

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: Oil4Egg

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2020
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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