Clinical trial NCT05413954: To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
Official title: To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of waist circumference at 10 weeks
timeFrame: Baseline, 10 weeks
measure: Change from baseline of waist circumference at 5 weeks
timeFrame: Baseline, 5 weeks
Secondary outcomes:
measure: Satiety
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Red blood cells fatty acid pattern
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Plasma fatty acid pattern
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Plasma triglyceride
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Plasma LDL cholesterol
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Plasma total cholesterol
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Plasma HDL cholesterol
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Plasma non-HDL cholesterol
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Glycemia
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Insulinemia
timeFrame: Baseline, 5 weeks, 10 weeks
measure: HOMA (Homeostatic Model Assessment for Insulin Resistance)
timeFrame: Baseline, 5 weeks, 10 weeks
measure: QUICKI
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Body weight
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Impedancemeter lean mass
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Impedancemeter fat mass
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Hip circumference
timeFrame: Baseline, 5 weeks, 10 weeks
measure: CRP (c-reactive protein)
timeFrame: Baseline,10 weeks
measure: Oxidized LDL
timeFrame: Baseline,10 weeks
measure: Endothelial status
timeFrame: Baseline,10 weeks
measure: Liver stiffness
timeFrame: Baseline,10 weeks
measure: Liver steatosis
timeFrame: Baseline,10 weeks
measure: Subcutaneous fat area evaluated by computed tomography (CT) scan
timeFrame: Baseline,10 weeks
measure: Visceral fat area evaluated by computed tomography (CT) scan
timeFrame: Baseline,10 weeks
measure: Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan
timeFrame: Baseline,10 weeks
measure: Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan
timeFrame: Baseline,10 weeks
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: UCLouvain - CICN
Study officials:
References: