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

Not Applicable

Completed

• Conditions: Abdominal Obesity
• Interventions: Other: Control; Other: Test

• Registration Number: NCT05413954
• Lead Sponsor: Université Catholique de Louvain

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-22
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Study First Submitted: 2022-05-30
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Study First Posted: 2022-06-10
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Control snack
Test	Test	Test snack

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Satiety	Baseline, 5 weeks, 10 weeks	Visual analog scale (between 0 = no satiety to 100 = complete satiety)
Plasma triglyceride	Baseline, 5 weeks, 10 weeks
Plasma non-HDL cholesterol	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 total cholesterol	Baseline, 5 weeks, 10 weeks
Plasma HDL cholesterol	Baseline, 5 weeks, 10 weeks
Insulinemia	Baseline, 5 weeks, 10 weeks
CRP (c-reactive protein)	Baseline,10 weeks
Oxidized LDL	Baseline,10 weeks
Plasma LDL cholesterol	Baseline, 5 weeks, 10 weeks
Glycemia	Baseline, 5 weeks, 10 weeks
HOMA (Homeostatic Model Assessment for Insulin Resistance)	Baseline, 5 weeks, 10 weeks
Impedancemeter lean mass	Baseline, 5 weeks, 10 weeks
Liver stiffness	Baseline,10 weeks	Transient elastography
Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan	Baseline,10 weeks
Hip circumference	Baseline, 5 weeks, 10 weeks
Liver steatosis	Baseline,10 weeks	Controlled attenuation parameter (CAP)
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
Body weight	Baseline, 5 weeks, 10 weeks
Endothelial status	Baseline,10 weeks	HbNO (hemoglobin-NO adduct)
QUICKI	Baseline, 5 weeks, 10 weeks
Impedancemeter fat mass	Baseline, 5 weeks, 10 weeks

Trial Locations

Locations (1)

UCLouvain - CICN; 🇧🇪 Louvain-la-Neuve, Belgium