Center of Investigation in Clinical Nutrition
Louvain-la-Neuve, 1348, Belgium
NCT Number: NCT04583657
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.
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Notify Me35 year–75 year
All sexes
Interventional
Not applicable
Louvain-la-Neuve, 1348, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consumption of two eggs (control or test) per day during three months
Time frame: Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)
Glycated haemoglobin (HbA1c) in blood samples
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
blood samples
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Impedancemeter
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Measuring tape
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Measuring tape
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Impedancemeter
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Impedancemeter
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
Impedancemeter
Time frame: baseline (visit 1) and Day 90 (last visit 4)
blood samples
Time frame: baseline (visit 1) and Day 90 (last visit 4)
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Time frame: baseline (visit 1) and Day 90 (last visit 4)
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Time frame: baseline (visit 1) and Day 90 (last visit 4)
blood samples
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
visual analog scale questionnaire
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
visual analog scale questionnaire
Time frame: baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
SF36 questionnaire
Time frame: baseline (visit 1) and Day 90 (last visit 4)
Tonometry
Time frame: baseline (visit 1) and Day 90 (last visit 4)
Tonometry
Time frame: baseline (visit 1) and Day 90 (last visit 4)
Tensiometer
Time frame: baseline (visit 1) and Day 90 (last visit 4)
Tensiometer
Time frame: Day 30 (visit 2) and Day 60 (visit 3)
Glycated haemoglobin in blood sample
Université Catholique de Louvain
Other
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
Acronym: Oil4Egg
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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