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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05413954
Other study ID # Omegasnack
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2020
Est. completion date June 11, 2021

Study information

Verified date June 2022
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 11, 2021
Est. primary completion date June 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Control
Control group ate snacks composed of dried vegetables, one classical egg yolk and 2.3g of sunflower oil during 10 weeks
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

Locations

Country Name City State
Belgium UCLouvain - CICN Louvain-la-Neuve

Sponsors (1)

Lead Sponsor Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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