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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Sedentary Behavior; Abdominal Obesity
• Intervention / Treatment: Other: Eggs

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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%.	Other: Eggs; Consumption of two eggs (control or test) per day during three months
Experimental: 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%)	Other: Eggs; Consumption of two eggs (control or test) per day during three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated haemoglobin (HbA1c)	Glycated haemoglobin (HbA1c) in blood samples	Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Insulin	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Homeostatic model assessment (HOMA)	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)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Triglycerides	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Total cholesterol	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
low-density lipoprotein (LDL) cholesterol	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
high-density lipoprotein (HDL) cholesterol	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)	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	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Fatty acid pattern plasma	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Urea	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Uric acid	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Creatinine	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Glomerular filtration rate (GFR)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Sodium (Na)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Potassium (K)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Chlore (Cl)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Phosphate (P)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Alanine transaminase (ALAT)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Aspartate aminotransferase (ASAT)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Gamma-glutamyl transferase (GGT)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Alkaline phosphatase (ALP)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Lipase	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Haemoglobin	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Mean corpuscular volume (MCV)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Mean corpuscular hemoglobin concentration (MCHC)	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Red blood cells	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
White blood cells	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Blood cell count	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Reticulocytes	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Haematocrit	blood samples	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Body weight	Impedancemeter	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Waist circumference	Measuring tape	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Hip circumference	Measuring tape	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Fat mass	Impedancemeter	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Lean mass	Impedancemeter	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Visceral fat mass	Impedancemeter	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
International normalized ratio (INR)	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Activated clotting time (ACT)	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Iron	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Transferrin	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Ferritin	blood samples	baseline (visit 1) and Day 90 (last visit 4)
% transferrin saturation	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Vitamin B12	blood samples	baseline (visit 1) and Day 90 (last visit 4)
25-hydroxy-vitamin D	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Protein	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Albumin	blood samples	baseline (visit 1) and Day 90 (last visit 4)
C-reactive protein (CRP)	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Interleukin-6	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Interleukin-1b	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Tumor necrosis factor alpha (TNFa)	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Oxidized low-density lipoprotein (LDLox)	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Nitrosylated hemoglobin (HbNO)	blood samples	baseline (visit 1) and Day 90 (last visit 4)
Satiety	visual analog scale questionnaire	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Intestinal tolerance	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)	SF36 questionnaire	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Reactive hyperemia index (LnRHI)	Tonometry	baseline (visit 1) and Day 90 (last visit 4)
Augmentation index normalized for heart rate (AI@75bpm)	Tonometry	baseline (visit 1) and Day 90 (last visit 4)
Systolic blood pressure	Tensiometer	baseline (visit 1) and Day 90 (last visit 4)
Diastolic blood pressure	Tensiometer	baseline (visit 1) and Day 90 (last visit 4)
Glycated haemoglobin (HbA1c)	Glycated haemoglobin in blood sample	Day 30 (visit 2) and Day 60 (visit 3)

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Study Director: Yvan Larondelle, Prof, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Metabolic Diseases; Obesity, Abdominal
• Other Study ID Numbers: Oil4Egg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No