NCT05413954CompletedNot Applicable
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
Université Catholique de Louvain2 sites in 1 country24 target enrollmentStarted: October 22, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Change from baseline of waist circumference at 10 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Liver steatosis(Baseline,10 weeks)
- Impedancemeter lean mass(Baseline, 5 weeks, 10 weeks)
- QUICKI(Baseline, 5 weeks, 10 weeks)
- Satiety(Baseline, 5 weeks, 10 weeks)
- Plasma triglyceride(Baseline, 5 weeks, 10 weeks)
- Plasma non-HDL cholesterol(Baseline, 5 weeks, 10 weeks)
- Liver stiffness(Baseline,10 weeks)
- Red blood cells fatty acid pattern(Baseline, 5 weeks, 10 weeks)
- Plasma fatty acid pattern(Baseline, 5 weeks, 10 weeks)
- Plasma total cholesterol(Baseline, 5 weeks, 10 weeks)
- Plasma HDL cholesterol(Baseline, 5 weeks, 10 weeks)
- Insulinemia(Baseline, 5 weeks, 10 weeks)
- CRP (c-reactive protein)(Baseline,10 weeks)
- Oxidized LDL(Baseline,10 weeks)
- Plasma LDL cholesterol(Baseline, 5 weeks, 10 weeks)
- Glycemia(Baseline, 5 weeks, 10 weeks)
- HOMA (Homeostatic Model Assessment for Insulin Resistance)(Baseline, 5 weeks, 10 weeks)
- Body weight(Baseline, 5 weeks, 10 weeks)
- Endothelial status(Baseline,10 weeks)
- Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan(Baseline,10 weeks)
- Impedancemeter fat mass(Baseline, 5 weeks, 10 weeks)
- Hip circumference(Baseline, 5 weeks, 10 weeks)
- Subcutaneous fat area evaluated by computed tomography (CT) scan(Baseline,10 weeks)
- Visceral fat area evaluated by computed tomography (CT) scan(Baseline,10 weeks)
- Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan(Baseline,10 weeks)
Investigators
Study Sites (2)
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