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

Healthy Clinical Trial

— Oil4Egg  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04583657
• Other study ID #: Oil4Egg
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: October 2020
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Healthy
• Metabolic Diseases
• Obesity, Abdominal
• Sedentary Behavior

Intervention

Other:
• Eggs
Consumption of two eggs (control or test) per day during three months

Locations

Country	Name	City	State
Belgium	Center of Investigation in Clinical Nutrition	Louvain-La-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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