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

Abdominal Obesity Clinical Trial

— Omegasnack  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413954
• Other study ID #: Omegasnack
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: June 11, 2021

Study information

• Verified date: June 2022
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
Belgium	UCLouvain - CICN	Louvain-la-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of waist circumference at 10 weeks		Baseline, 10 weeks
Primary	Change from baseline of waist circumference at 5 weeks		Baseline, 5 weeks
Secondary	Satiety	Visual analog scale (between 0 = no satiety to 100 = complete satiety)	Baseline, 5 weeks, 10 weeks
Secondary	Red blood cells fatty acid pattern		Baseline, 5 weeks, 10 weeks
Secondary	Plasma fatty acid pattern		Baseline, 5 weeks, 10 weeks
Secondary	Plasma triglyceride		Baseline, 5 weeks, 10 weeks
Secondary	Plasma LDL cholesterol		Baseline, 5 weeks, 10 weeks
Secondary	Plasma total cholesterol		Baseline, 5 weeks, 10 weeks
Secondary	Plasma HDL cholesterol		Baseline, 5 weeks, 10 weeks
Secondary	Plasma non-HDL cholesterol		Baseline, 5 weeks, 10 weeks
Secondary	Glycemia		Baseline, 5 weeks, 10 weeks
Secondary	Insulinemia		Baseline, 5 weeks, 10 weeks
Secondary	HOMA (Homeostatic Model Assessment for Insulin Resistance)		Baseline, 5 weeks, 10 weeks
Secondary	QUICKI		Baseline, 5 weeks, 10 weeks
Secondary	Body weight		Baseline, 5 weeks, 10 weeks
Secondary	Impedancemeter lean mass		Baseline, 5 weeks, 10 weeks
Secondary	Impedancemeter fat mass		Baseline, 5 weeks, 10 weeks
Secondary	Hip circumference		Baseline, 5 weeks, 10 weeks
Secondary	CRP (c-reactive protein)		Baseline,10 weeks
Secondary	Oxidized LDL		Baseline,10 weeks
Secondary	Endothelial status	HbNO (hemoglobin-NO adduct)	Baseline,10 weeks
Secondary	Liver stiffness	Transient elastography	Baseline,10 weeks
Secondary	Liver steatosis	Controlled attenuation parameter (CAP)	Baseline,10 weeks
Secondary	Subcutaneous fat area evaluated by computed tomography (CT) scan		Baseline,10 weeks
Secondary	Visceral fat area evaluated by computed tomography (CT) scan		Baseline,10 weeks
Secondary	Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan		Baseline,10 weeks
Secondary	Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan		Baseline,10 weeks