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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Obesity
• Intervention / Treatment: Other: Control; Other: Test

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-la-Neuve, Belgium, 1348
    • UCLouvain - CICN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Control snack	Other: Control; Control group ate snacks composed of dried vegetables, one classical egg yolk and 2.3g of sunflower oil during 10 weeks
Experimental: Test; Test snack	Other: Test; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: Omegasnack

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No