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

NCT ID: NCT04583657

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2020-04-20

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.

Conditions

Healthy; Abdominal Obesity; Sedentary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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%.

Group Type: PLACEBO_COMPARATOR

Eggs

Intervention Type: OTHER

Consumption of two eggs (control or test) per day during three months

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%)

Group Type: EXPERIMENTAL

Eggs

Intervention Type: OTHER

Consumption of two eggs (control or test) per day during three months

Interventions

Eggs

Consumption of two eggs (control or test) per day during three months

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvan Larondelle, Prof

Role: STUDY_DIRECTOR

Université Catholique de Louvain

Locations

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, , Belgium

Countries

Belgium

Other Identifiers

Oil4Egg

Identifier Type: -

Identifier Source: org_study_id