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

Study Overview
=================
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.

Official 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

Conditions
-----------------
Healthy, Abdominal Obesity, Sedentary Behavior

Intervention / Treatment
-----------------
* Other: Eggs


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This monocentric study is an interventional, randomized, double-blind, controlled study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* Consumption of two eggs (control or test) per day during three months<br>|
| Experimental: Test<br>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<br>* Consumption of two eggs (control or test) per day during three months<br>|

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) |