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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04583657
Acronym
Oil4Egg
Enrollment
24
Registered
2020-10-12
Start date
2019-05-20
Completion date
2020-04-20
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Obesity, Healthy, Sedentary Behavior

Brief summary

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.

Detailed description

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.

Interventions

OTHEREggs

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

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glycated haemoglobin (HbA1c)Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)Glycated haemoglobin (HbA1c) in blood samples

Secondary

MeasureTime frameDescription
Insulinbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Homeostatic model assessment (HOMA)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Quantitative insulin sensitivity check index (QUICKI)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Triglyceridesbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Total cholesterolbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
low-density lipoprotein (LDL) cholesterolbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
high-density lipoprotein (HDL) cholesterolbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
non-high-density lipoprotein cholesterol (non-HDL)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Fatty acid pattern in red blood cellsbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Fatty acid pattern plasmabaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Ureabaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Uric acidbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Creatininebaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Glomerular filtration rate (GFR)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Sodium (Na)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Potassium (K)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Chlore (Cl)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Phosphate (P)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Alanine transaminase (ALAT)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Aspartate aminotransferase (ASAT)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Gamma-glutamyl transferase (GGT)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Alkaline phosphatase (ALP)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Lipasebaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Haemoglobinbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Mean corpuscular volume (MCV)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Mean corpuscular hemoglobin concentration (MCHC)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Red blood cellsbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
White blood cellsbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Blood cell countbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Reticulocytesbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Haematocritbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Body weightbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)Impedancemeter
Waist circumferencebaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)Measuring tape
Hip circumferencebaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)Measuring tape
Fat massbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)Impedancemeter
Lean massbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)Impedancemeter
Visceral fat massbaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)Impedancemeter
International normalized ratio (INR)baseline (visit 1) and Day 90 (last visit 4)blood samples
Activated clotting time (ACT)baseline (visit 1) and Day 90 (last visit 4)blood samples
Ironbaseline (visit 1) and Day 90 (last visit 4)blood samples
Transferrinbaseline (visit 1) and Day 90 (last visit 4)blood samples
Ferritinbaseline (visit 1) and Day 90 (last visit 4)blood samples
% transferrin saturationbaseline (visit 1) and Day 90 (last visit 4)blood samples
Vitamin B12baseline (visit 1) and Day 90 (last visit 4)blood samples
25-hydroxy-vitamin Dbaseline (visit 1) and Day 90 (last visit 4)blood samples
Proteinbaseline (visit 1) and Day 90 (last visit 4)blood samples
Albuminbaseline (visit 1) and Day 90 (last visit 4)blood samples
C-reactive protein (CRP)baseline (visit 1) and Day 90 (last visit 4)blood samples
Interleukin-6baseline (visit 1) and Day 90 (last visit 4)blood samples
Interleukin-1bbaseline (visit 1) and Day 90 (last visit 4)blood samples
Tumor necrosis factor alpha (TNFa)baseline (visit 1) and Day 90 (last visit 4)blood samples
Oxidized low-density lipoprotein (LDLox)baseline (visit 1) and Day 90 (last visit 4)blood samples
Nitrosylated hemoglobin (HbNO)baseline (visit 1) and Day 90 (last visit 4)blood samples
Satietybaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)visual analog scale questionnaire
Glucosebaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)blood samples
Quality of life 36-item short-form survey (SF36)baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)SF36 questionnaire
Reactive hyperemia index (LnRHI)baseline (visit 1) and Day 90 (last visit 4)Tonometry
Augmentation index normalized for heart rate (AI@75bpm)baseline (visit 1) and Day 90 (last visit 4)Tonometry
Systolic blood pressurebaseline (visit 1) and Day 90 (last visit 4)Tensiometer
Diastolic blood pressurebaseline (visit 1) and Day 90 (last visit 4)Tensiometer
Glycated haemoglobin (HbA1c)Day 30 (visit 2) and Day 60 (visit 3)Glycated haemoglobin in blood sample
Intestinal tolerancebaseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)visual analog scale questionnaire

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026