Status:
COMPLETED
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
Lead Sponsor:
Université Catholique de Louvain
Conditions:
Abdominal Obesity
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05413954
Start Date
October 22 2020
End Date
June 11 2021
Last Update
June 10 2022
Active Locations (1)
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1
UCLouvain - CICN
Louvain-la-Neuve, Belgium, 1348