To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs

Study Overview
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Brief Summary
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In a previous study, 24 volunteers consumed two conventional eggs or two eggs naturally enriched with omega 3, 5 and 7 every day for 3 months. It was shown that these eggs were well tolerated and that the omega enrichment led to a reduction in waist circumference of 3 cm in 3 months. The objective of Omegasnack study was therefore to go further in the evaluation of these effects on waist circumference; 1) confirm the effects of these eggs on waist circumference when included in a snack, 2) determine whether this reduction in waist circumference is linked to a reduction in muscle and/or fat mass (subcutaneous and/or visceral) and 3) evaluate whether these effects are associated with a modification in the accumulation of ectopic fat in the muscle and/or liver.

Official Title
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To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs

Conditions
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Abdominal Obesity

Intervention / Treatment
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* Other: Control
* Other: Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman or man, aged of 18 to 75 years; Abdominal obesity: waist circumference for men > 94cm and > 80cm for women; Body mass index ≥ 25kg/m2 and ≤30kg/m2; For women: use of effective contraception; Provision of signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; French speaker. Exclusion Criteria: Uncontrolled systolic blood pressure > 160/100 mmHg; For premenopausal women: pregnant women or women planning to get pregnant within 3 months or lactating women; For menopausal women: less than 6 months of menopause; For Perimenopausal women: presenting symptoms; Type II diabetes (controlled or uncontrolled), Type I diabetes; Medical history or actual cardiovascular disease (myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy); Medical history or actual severe psychiatric, hepatic, pancreatic, kidney, pulmonary or gastrointestinal problem Thyroid disorder; Cancer < 3 years before the screening visit; Smokers or who have stopped smoking within the last 6 months before the screening visit; Subject presenting allergy or food intolerance to eggs; Subjects who are not able to understand and follow study procedures; Drug addiction problem (regular consumption); Recent change of body weight > 7% (< 2 months before the inclusion); Within 1 month 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 and/or lipid metabolism; Current or recent (< 2 months before the screening visit) intake of dietary supplements rich in n-3 polyunsaturated fatty acid (including tablets, pills, capsules, enriched-oils); Vegan diet; Consumption of fish > 3 times per week; Women who drink more than 2 glasses of alcohol per day (> 20 g of alcohol per day or > 140g/week) or men who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day or more than 210g/week); LDL > 159 mg/dl or Total cholesterol > 239 mg/dl; Subjects having participated to another clinical trial < 1 month before the screening test visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control snack | Other: Control<br>* Control group ate snacks composed of dried vegetables, one classical egg yolk and 2.3g of sunflower oil during 10 weeks<br>|
| Experimental: Test<br>Test snack | Other: Test<br>* Tes group ate snacks composed of dried vegetables, one test egg yolk naturally enriched in rumenic acid, docosahexaenoic acid and punicic acid, 0.34g of pomegranate seed oil and 2.26g of olive oil during 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of waist circumference at 10 weeks |  | Baseline, 10 weeks | 
| Change from baseline of waist circumference at 5 weeks |  | Baseline, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety | Visual analog scale (between 0 = no satiety to 100 = complete satiety) | Baseline, 5 weeks, 10 weeks | 
| Red blood cells fatty acid pattern |  | Baseline, 5 weeks, 10 weeks | 
| Plasma fatty acid pattern |  | Baseline, 5 weeks, 10 weeks | 
| Plasma triglyceride |  | Baseline, 5 weeks, 10 weeks | 
| Plasma LDL cholesterol |  | Baseline, 5 weeks, 10 weeks | 
| Plasma total cholesterol |  | Baseline, 5 weeks, 10 weeks | 
| Plasma HDL cholesterol |  | Baseline, 5 weeks, 10 weeks | 
| Plasma non-HDL cholesterol |  | Baseline, 5 weeks, 10 weeks | 
| Glycemia |  | Baseline, 5 weeks, 10 weeks | 
| Insulinemia |  | Baseline, 5 weeks, 10 weeks | 
| HOMA (Homeostatic Model Assessment for Insulin Resistance) |  | Baseline, 5 weeks, 10 weeks | 
| QUICKI |  | Baseline, 5 weeks, 10 weeks | 
| Body weight |  | Baseline, 5 weeks, 10 weeks | 
| Impedancemeter lean mass |  | Baseline, 5 weeks, 10 weeks | 
| Impedancemeter fat mass |  | Baseline, 5 weeks, 10 weeks | 
| Hip circumference |  | Baseline, 5 weeks, 10 weeks | 
| CRP (c-reactive protein) |  | Baseline,10 weeks | 
| Oxidized LDL |  | Baseline,10 weeks | 
| Endothelial status | HbNO (hemoglobin-NO adduct) | Baseline,10 weeks | 
| Liver stiffness | Transient elastography | Baseline,10 weeks | 
| Liver steatosis | Controlled attenuation parameter (CAP) | Baseline,10 weeks | 
| Subcutaneous fat area evaluated by computed tomography (CT) scan |  | Baseline,10 weeks | 
| Visceral fat area evaluated by computed tomography (CT) scan |  | Baseline,10 weeks | 
| Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan |  | Baseline,10 weeks | 
| Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan |  | Baseline,10 weeks |