Clinical trial NCT04583657: Intestinal Tolerance & Health Effects of Daily Consumption of Two Eggs With Fatty Acid Profile Related to Metabolic Disorders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Abdominal Obesity
Sedentary Behavior
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This monocentric study is an interventional, randomized, double-blind, controlled study.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Glycated haemoglobin (HbA1c)
timeFrame: Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)
Secondary outcomes:
measure: Glucose
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Insulin
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Homeostatic model assessment (HOMA)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Quantitative insulin sensitivity check index (QUICKI)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Triglycerides
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Total cholesterol
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: low-density lipoprotein (LDL) cholesterol
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: high-density lipoprotein (HDL) cholesterol
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: non-high-density lipoprotein cholesterol (non-HDL)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Fatty acid pattern in red blood cells
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Fatty acid pattern plasma
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Urea
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Uric acid
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Creatinine
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Glomerular filtration rate (GFR)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Sodium (Na)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Potassium (K)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Chlore (Cl)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Phosphate (P)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Alanine transaminase (ALAT)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Aspartate aminotransferase (ASAT)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Gamma-glutamyl transferase (GGT)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Alkaline phosphatase (ALP)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Lipase
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Haemoglobin
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Mean corpuscular volume (MCV)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Red blood cells
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: White blood cells
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Blood cell count
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Reticulocytes
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Haematocrit
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Body weight
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Waist circumference
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Hip circumference
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Fat mass
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Lean mass
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Visceral fat mass
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: International normalized ratio (INR)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Activated clotting time (ACT)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Iron
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Transferrin
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Ferritin
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: % transferrin saturation
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Vitamin B12
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: 25-hydroxy-vitamin D
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Protein
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Albumin
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: C-reactive protein (CRP)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Interleukin-6
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Interleukin-1b
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Tumor necrosis factor alpha (TNFa)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Oxidized low-density lipoprotein (LDLox)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Nitrosylated hemoglobin (HbNO)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Satiety
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Intestinal tolerance
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Quality of life 36-item short-form survey (SF36)
timeFrame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
measure: Reactive hyperemia index (LnRHI)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Augmentation index normalized for heart rate (AI@75bpm)
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Systolic blood pressure
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Diastolic blood pressure
timeFrame: baseline (visit 1) and Day 90 (last visit 4)
measure: Glycated haemoglobin (HbA1c)
timeFrame: Day 30 (visit 2) and Day 60 (visit 3)
Other outcomes:
Locations:
city: Louvain-La-Neuve
country: Belgium
facility: Center of Investigation in Clinical Nutrition
Study officials:
affiliation: Université Catholique de Louvain
name: Yvan Larondelle, Prof
role: STUDY_DIRECTOR
References: