Abdominal ObesityOmegasnackNCT05413954
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
A study testing Test in people with Abdominal Obesity, run by Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Oct 2020to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Abdominal Obesity
- Being tested
- Control, Test
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Control group ate snacks composed of dried vegetables, one classical egg yolk and 2.3g of sunflower oil during 10 weeks
TestOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control snack Receives: Other: Control |
| Test | Experimental | Test snack Receives: Other: Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of waist circumference at 10 weeks
Measured: Baseline, 10 weeks
Change from baseline of waist circumference at 5 weeks
Measured: Baseline, 5 weeks
Secondary outcomes (25)
Satiety
Visual analog scale (between 0 = no satiety to 100 = complete satiety)
Measured: Baseline, 5 weeks, 10 weeks
Red blood cells fatty acid pattern
Measured: Baseline, 5 weeks, 10 weeks
Plasma fatty acid pattern
Measured: Baseline, 5 weeks, 10 weeks
Plasma triglyceride
Measured: Baseline, 5 weeks, 10 weeks
Plasma LDL cholesterol
Measured: Baseline, 5 weeks, 10 weeks
Plasma total cholesterol
Measured: Baseline, 5 weeks, 10 weeks
Plasma HDL cholesterol
Measured: Baseline, 5 weeks, 10 weeks
Plasma non-HDL cholesterol
Measured: Baseline, 5 weeks, 10 weeks
Glycemia
Measured: Baseline, 5 weeks, 10 weeks
Insulinemia
Measured: Baseline, 5 weeks, 10 weeks
HOMA (Homeostatic Model Assessment for Insulin Resistance)
Measured: Baseline, 5 weeks, 10 weeks
QUICKI
Measured: Baseline, 5 weeks, 10 weeks
Body weight
Measured: Baseline, 5 weeks, 10 weeks
Impedancemeter lean mass
Measured: Baseline, 5 weeks, 10 weeks
Impedancemeter fat mass
Measured: Baseline, 5 weeks, 10 weeks
Hip circumference
Measured: Baseline, 5 weeks, 10 weeks
CRP (c-reactive protein)
Measured: Baseline,10 weeks
Oxidized LDL
Measured: Baseline,10 weeks
Endothelial status
HbNO (hemoglobin-NO adduct)
Measured: Baseline,10 weeks
Liver stiffness
Transient elastography
Measured: Baseline,10 weeks
Liver steatosis
Controlled attenuation parameter (CAP)
Measured: Baseline,10 weeks
Subcutaneous fat area evaluated by computed tomography (CT) scan
Measured: Baseline,10 weeks
Visceral fat area evaluated by computed tomography (CT) scan
Measured: Baseline,10 weeks
Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan
Measured: Baseline,10 weeks
Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan
Measured: Baseline,10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start22 Oct 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413954
- Sponsor's protocol ID
- Omegasnack
- Acronym
- Omegasnack
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
- ClinicalTrials.gov ID
- NCT05413954
- Acronym / sponsor ID
- Omegasnack / Omegasnack
- Conditions
- Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlControl snack |
| Test | Experimental | Other: TestTest snack |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlControl group ate snacks composed of dried vegetables, one classical egg yolk and 2.3g of sunflower oil during 10 weeks | Other | Control |
| TestTes 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 | Other | Test |
Primary outcome
Change from baseline of waist circumference at 10 weeks
Time frame: Baseline, 10 weeks
Change from baseline of waist circumference at 5 weeks
Time frame: Baseline, 5 weeks
25 secondary outcomes
Satiety
Time frame: Baseline, 5 weeks, 10 weeks
Red blood cells fatty acid pattern
Time frame: Baseline, 5 weeks, 10 weeks
Plasma fatty acid pattern
Time frame: Baseline, 5 weeks, 10 weeks
Plasma triglyceride
Time frame: Baseline, 5 weeks, 10 weeks
Plasma LDL cholesterol
Time frame: Baseline, 5 weeks, 10 weeks
Plasma total cholesterol
Time frame: Baseline, 5 weeks, 10 weeks
Plasma HDL cholesterol
Time frame: Baseline, 5 weeks, 10 weeks
Plasma non-HDL cholesterol
Time frame: Baseline, 5 weeks, 10 weeks
Glycemia
Time frame: Baseline, 5 weeks, 10 weeks
Insulinemia
Time frame: Baseline, 5 weeks, 10 weeks
HOMA (Homeostatic Model Assessment for Insulin Resistance)
Time frame: Baseline, 5 weeks, 10 weeks
QUICKI
Time frame: Baseline, 5 weeks, 10 weeks
Body weight
Time frame: Baseline, 5 weeks, 10 weeks
Impedancemeter lean mass
Time frame: Baseline, 5 weeks, 10 weeks
Impedancemeter fat mass
Time frame: Baseline, 5 weeks, 10 weeks
Hip circumference
Time frame: Baseline, 5 weeks, 10 weeks
CRP (c-reactive protein)
Time frame: Baseline,10 weeks
Oxidized LDL
Time frame: Baseline,10 weeks
Endothelial status
Time frame: Baseline,10 weeks
Liver stiffness
Time frame: Baseline,10 weeks
Liver steatosis
Time frame: Baseline,10 weeks
Subcutaneous fat area evaluated by computed tomography (CT) scan
Time frame: Baseline,10 weeks
Visceral fat area evaluated by computed tomography (CT) scan
Time frame: Baseline,10 weeks
Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan
Time frame: Baseline,10 weeks
Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan
Time frame: Baseline,10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 42235640Denos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test in people with Abdominal Obesity, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of waist circumference at 10 weeks (time frame: Baseline, 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.