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

Primary Purpose

Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Control
Test
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • UCLouvain - CICN

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Test

Arm Description

Control snack

Test snack

Outcomes

Primary Outcome Measures

Change from baseline of waist circumference at 10 weeks
Change from baseline of waist circumference at 5 weeks

Secondary Outcome Measures

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

Full Information

First Posted
May 30, 2022
Last Updated
June 7, 2022
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT05413954
Brief Title
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
Acronym
Omegasnack
Official Title
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control snack
Arm Title
Test
Arm Type
Experimental
Arm Description
Test snack
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Control group ate snacks composed of dried vegetables, one classical egg yolk and 2.3g of sunflower oil during 10 weeks
Intervention Type
Other
Intervention Name(s)
Test
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline of waist circumference at 10 weeks
Time Frame
Baseline, 10 weeks
Title
Change from baseline of waist circumference at 5 weeks
Time Frame
Baseline, 5 weeks
Secondary Outcome Measure Information:
Title
Satiety
Description
Visual analog scale (between 0 = no satiety to 100 = complete satiety)
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Red blood cells fatty acid pattern
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Plasma fatty acid pattern
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Plasma triglyceride
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Plasma LDL cholesterol
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Plasma total cholesterol
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Plasma HDL cholesterol
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Plasma non-HDL cholesterol
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Glycemia
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Insulinemia
Time Frame
Baseline, 5 weeks, 10 weeks
Title
HOMA (Homeostatic Model Assessment for Insulin Resistance)
Time Frame
Baseline, 5 weeks, 10 weeks
Title
QUICKI
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Body weight
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Impedancemeter lean mass
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Impedancemeter fat mass
Time Frame
Baseline, 5 weeks, 10 weeks
Title
Hip circumference
Time Frame
Baseline, 5 weeks, 10 weeks
Title
CRP (c-reactive protein)
Time Frame
Baseline,10 weeks
Title
Oxidized LDL
Time Frame
Baseline,10 weeks
Title
Endothelial status
Description
HbNO (hemoglobin-NO adduct)
Time Frame
Baseline,10 weeks
Title
Liver stiffness
Description
Transient elastography
Time Frame
Baseline,10 weeks
Title
Liver steatosis
Description
Controlled attenuation parameter (CAP)
Time Frame
Baseline,10 weeks
Title
Subcutaneous fat area evaluated by computed tomography (CT) scan
Time Frame
Baseline,10 weeks
Title
Visceral fat area evaluated by computed tomography (CT) scan
Time Frame
Baseline,10 weeks
Title
Skeletal muscle index (total skeletal muscle area normalized for stature) evaluated by computed tomography (CT) scan
Time Frame
Baseline,10 weeks
Title
Muscular radiation attenuation (fat accumulation in muscle) evaluated by computed tomography (CT) scan
Time Frame
Baseline,10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
UCLouvain - CICN
City
Louvain-la-Neuve
ZIP/Postal Code
1348
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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