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

Not Applicable

Completed

• Conditions: Abdominal Obesity; Sedentary Behavior; Healthy
• Interventions: Other: Eggs

• Registration Number: NCT04583657
• Lead Sponsor: Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2019-05-20
• Primary Completion: 2020-04-20
• Study Completion: 2020-04-20
• Study First Submitted: 2020-09-03
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-05
• Last Update Submitted: 2020-10-05
• Study First Posted: 2020-10-12
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Eggs	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%.
Test	Eggs	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%)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intestinal tolerance	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	visual analog scale questionnaire
Reactive hyperemia index (LnRHI)	baseline (visit 1) and Day 90 (last visit 4)	Tonometry
Glucose	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Insulin	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
Homeostatic model assessment (HOMA)	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
low-density lipoprotein (LDL) cholesterol	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Triglycerides	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Total cholesterol	baseline (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 cells	baseline (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
% transferrin saturation	baseline (visit 1) and Day 90 (last visit 4)	blood samples
high-density lipoprotein (HDL) cholesterol	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Fatty acid pattern plasma	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Urea	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Uric acid	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Creatinine	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
Vitamin B12	baseline (visit 1) 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
Lipase	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Haemoglobin	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
White blood cells	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Blood cell count	baseline (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 cells	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Reticulocytes	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Haematocrit	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	blood samples
Body weight	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	Impedancemeter
Waist circumference	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	Measuring tape
Hip circumference	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	Measuring tape
Lean mass	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	Impedancemeter
Fat mass	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	Impedancemeter
Visceral fat mass	baseline (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
Iron	baseline (visit 1) and Day 90 (last visit 4)	blood samples
Transferrin	baseline (visit 1) and Day 90 (last visit 4)	blood samples
Ferritin	baseline (visit 1) and Day 90 (last visit 4)	blood samples
25-hydroxy-vitamin D	baseline (visit 1) and Day 90 (last visit 4)	blood samples
Protein	baseline (visit 1) and Day 90 (last visit 4)	blood samples
Albumin	baseline (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-6	baseline (visit 1) and Day 90 (last visit 4)	blood samples
Interleukin-1b	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
Systolic blood pressure	baseline (visit 1) and Day 90 (last visit 4)	Tensiometer
Diastolic blood pressure	baseline (visit 1) and Day 90 (last visit 4)	Tensiometer
Tumor necrosis factor alpha (TNFa)	baseline (visit 1) and Day 90 (last visit 4)	blood samples
Satiety	baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)	visual analog scale questionnaire
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
Augmentation index normalized for heart rate (AI@75bpm)	baseline (visit 1) and Day 90 (last visit 4)	Tonometry
Glycated haemoglobin (HbA1c)	Day 30 (visit 2) and Day 60 (visit 3)	Glycated haemoglobin in blood sample
Nitrosylated hemoglobin (HbNO)	baseline (visit 1) and Day 90 (last visit 4)	blood samples

Trial Locations

Locations (1)

Center of Investigation in Clinical Nutrition; 🇧🇪 Louvain-La-Neuve, Belgium