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

U

Université Catholique de Louvain

Status

Completed

Conditions

Abdominal Obesity

Treatments

Other: Control
Other: Test

Study type

Interventional

Funder types

Other

Identifiers

NCT05413954
Omegasnack

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Control snack
Treatment:
Other: Control
Test
Experimental group
Description:
Test snack
Treatment:
Other: Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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