Intestinal Tolerance & Health Effects of Daily Consumption of Two Eggs With Fatty Acid Profile Related to Metabolic Disorders

NCT04583657 | Completed

• 1 other identifier: Oil4Egg
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study has two objectives: 1) to check that the daily consumption of two eggs with a particular fatty acid pattern rich in n-3 polyunsaturated fatty acids (α-linolenic acid, docosahexaenoic acid), conjugated-linoleic acid and conjugated-linolenic acid is well tolerated by the consumer ; 2) to evaluate the effects of the consumption of these eggs on health parameters in subjects presenting a risk of developing a metabolic disorder. This monocentric study is an interventional, randomized, double-blind, control study.

Conditions

Healthy; Abdominal Obesity; Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• Glycated haemoglobin (HbA1c)

  Glycated haemoglobin (HbA1c) in blood samples

  Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)

Secondary Outcomes (62)

• Glucose

  baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

• Insulin

  baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

• Homeostatic model assessment (HOMA)

  baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

• Quantitative insulin sensitivity check index (QUICKI)

  baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

• Triglycerides

  baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)

Study Arms (2)

Control

PLACEBO COMPARATOR

Consumption of two "classical eggs" per day during three months. The fatty acid pattern of those eggs is characterized by: total saturated fatty acid 34.25%, total monounsaturated fatty acid 47.68%, total n-6 polyunsaturated fatty acid 16.97%, total n-3 polyunsaturated fatty acid 1.10%.

Other: Eggs

Test

EXPERIMENTAL

Consumption of two test eggs per day during three months. These eggs are naturally enriched in n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids (total saturated fatty acid 31.74%, total monounsaturated fatty acid 28.09%, total n-6 polyunsaturated fatty acid 16.07%, total n-3 polyunsaturated fatty acid 6.51%)

Other: Eggs

Interventions

Eggs OTHER

Consumption of two eggs (control or test) per day during three months

Control; Test

Eligibility Criteria

• Age: 35 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 35 to 75 years
• Abdominal obesity : waist circumference for men \> 94cm and \> 80cm for women
• Practicing \< 2h of physical activity per week

You may not qualify if:

• Uncontrolled systolic blood pressure \> 160/100mmHg
• For premenopausal women: pregnant or lactating women
• For menopausal women: less than 6 months of menopause
• Perimenopausal women with symptoms
• Type II diabetes (fasted glycaemia ≥ 126mg/dl or HbA1c ≥ 6.5%), Type I diabetes
• Medical history or actual cardiovascular disease (myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
• Familial history of premature cardiovascular incident (in male first degree relative \< 55 years and in female first degree relative \< 65 years; myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
• Medical history or actual liver, pancreas, kidney, pulmonary or gastrointestinal problem
• Thyroid disorder
• Cancer \< 5 years before the screening visit
• Smokers or who have stopped smoking within 6 months before the screening visit
• Subject presenting allergy or food intolerance to eggs
• Subjects with psychiatric problems and/or using antipsychotics
• Drug addiction problem
• Recent change of body weight \> 5kg (\< 3 months before the screening visit)

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Center of Investigation in Clinical Nutrition

Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Conditions

Obesity, Abdominal; Sedentary Behavior

Interventions

Eggs

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yvan Larondelle, Prof

  Université Catholique de Louvain

  STUDY DIRECTOR

Study Design

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

Model Details: This monocentric study is an interventional, randomized, double-blind, controlled study.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 12, 2020
• Study Start: May 20, 2019
• Primary Completion: April 20, 2020
• Study Completion: April 20, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)