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

NCT05413954 | Completed

• 1 other identifier: Omegasnack
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (2)

• Change from baseline of waist circumference at 10 weeks

  Baseline, 10 weeks

• Change from baseline of waist circumference at 5 weeks

  Baseline, 5 weeks

Secondary Outcomes (25)

• Satiety

  Baseline, 5 weeks, 10 weeks

• Red blood cells fatty acid pattern

  Baseline, 5 weeks, 10 weeks

• Plasma fatty acid pattern

  Baseline, 5 weeks, 10 weeks

• Plasma triglyceride

  Baseline, 5 weeks, 10 weeks

• Plasma LDL cholesterol

  Baseline, 5 weeks, 10 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Control snack

Other: Control

Test

EXPERIMENTAL

Test snack

Other: Test

Interventions

Control OTHER

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

Control

Test OTHER

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

Test

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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);

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

UCLouvain - CICN

Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 10, 2022
• Study Start: October 22, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)