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OpenTrials
Completed

NCT Number: NCT05413954

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLouvain - CICN

Louvain-la-Neuve, 1348, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Other

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

Test

Other

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

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

    Time frame: Baseline, 5 weeks, 10 weeks

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

  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

    Time frame: Baseline,10 weeks

    HbNO (hemoglobin-NO adduct)

  20. Liver stiffness

    Time frame: Baseline,10 weeks

    Transient elastography

  21. Liver steatosis

    Time frame: Baseline,10 weeks

    Controlled attenuation parameter (CAP)

  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

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Acronym: Omegasnack

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2022
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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