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CompletedNCT05413954OmegasnackUpdated Jun 10, 2022

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

An interventional study of Control and Test in Abdominal Obesity, sponsored by Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-10.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2020, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Abdominal Obesity

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03

In context

Obesity, Abdominal

283 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.

This study's enrollment of 24 is below the median of 58 across 223 interventional studies indexed under Obesity, Abdominal.

Browse Obesity, Abdominal studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 151 studies on the registry; 57 are open to participants now.

Browse Université Catholique de Louvain studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    Control

    Control snack

    Other: Control

  • Experimental
    Test

    Test snack

    Other: Test

Interventions

  • OtherControl

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

  • OtherTest

    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

06

What researchers measure

Primary outcomes

  1. Change from baseline of waist circumference at 10 weeks

    Time frame: Baseline, 10 weeks

  2. Change from baseline of waist circumference at 5 weeks

    Time frame: Baseline, 5 weeks

Secondary outcomes

  1. Satiety

    Visual analog scale (between 0 = no satiety to 100 = complete satiety)

    Time frame: Baseline, 5 weeks, 10 weeks

  2. Red blood cells fatty acid pattern

    Time frame: Baseline, 5 weeks, 10 weeks

  3. Plasma fatty acid pattern

    Time frame: Baseline, 5 weeks, 10 weeks

  4. Plasma triglyceride

    Time frame: Baseline, 5 weeks, 10 weeks

  5. Plasma LDL cholesterol

    Time frame: Baseline, 5 weeks, 10 weeks

  6. Plasma total cholesterol

    Time frame: Baseline, 5 weeks, 10 weeks

  7. Plasma HDL cholesterol

    Time frame: Baseline, 5 weeks, 10 weeks

  8. Plasma non-HDL cholesterol

    Time frame: Baseline, 5 weeks, 10 weeks

  9. Glycemia

    Time frame: Baseline, 5 weeks, 10 weeks

  10. Insulinemia

    Time frame: Baseline, 5 weeks, 10 weeks

  11. HOMA (Homeostatic Model Assessment for Insulin Resistance)

    Time frame: Baseline, 5 weeks, 10 weeks

  12. QUICKI

    Time frame: Baseline, 5 weeks, 10 weeks

  13. Body weight

    Time frame: Baseline, 5 weeks, 10 weeks

  14. Impedancemeter lean mass

    Time frame: Baseline, 5 weeks, 10 weeks

  15. Impedancemeter fat mass

    Time frame: Baseline, 5 weeks, 10 weeks

  16. Hip circumference

    Time frame: Baseline, 5 weeks, 10 weeks

  17. CRP (c-reactive protein)

    Time frame: Baseline,10 weeks

  18. Oxidized LDL

    Time frame: Baseline,10 weeks

  19. Endothelial status

    HbNO (hemoglobin-NO adduct)

    Time frame: Baseline,10 weeks

  20. Liver stiffness

    Transient elastography

    Time frame: Baseline,10 weeks

  21. Liver steatosis

    Controlled attenuation parameter (CAP)

    Time frame: Baseline,10 weeks

  22. Subcutaneous fat area evaluated by computed tomography (CT) scan

    Time frame: Baseline,10 weeks

  23. Visceral fat area evaluated by computed tomography (CT) scan

    Time frame: Baseline,10 weeks

  24. Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan

    Time frame: Baseline,10 weeks

  25. Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan

    Time frame: Baseline,10 weeks

07

Study locations

1 site
  • UCLouvain - CICN
    Louvain-la-Neuve, 1348, Belgium
08

References and documents

Publications

  • Denos C, Nain CW, Pachikian B, Hdidou S, Rasse C, Dierge E, Debier C, Trefois P, Larondelle Y, Lanthier N. Effects of crackers enriched with polyunsaturated fatty acids with benefits for improving metabolic parameters: A double-blind randomized controlled trial in subjects with overweight. Clin Nutr ESPEN. 2026 Aug;74:103370. doi: 10.1016/j.clnesp.2026.103370. Epub 2026 Jun 2. PubMed 42235640 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05413954
Lead sponsor
Université Catholique de Louvain
Responsible party
Sponsor
First posted
Jun 10, 2022
Start date
Oct 22, 2020
Primary completion
Jun 11, 2021
Completion
Jun 11, 2021
Last update
Jun 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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