Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT04583657
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2020-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intestinal Tolerance & Health Effects of Daily Consumption of Two Eggs With Fatty Acid Profile Related to Metabolic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004531', 'term': 'Eggs'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This monocentric study is an interventional, randomized, double-blind, controlled study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated haemoglobin (HbA1c)', 'timeFrame': 'Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)', 'description': 'Glycated haemoglobin (HbA1c) in blood samples'}], 'secondaryOutcomes': [{'measure': 'Glucose', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Insulin', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Homeostatic model assessment (HOMA)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Quantitative insulin sensitivity check index (QUICKI)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Triglycerides', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Total cholesterol', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'low-density lipoprotein (LDL) cholesterol', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'high-density lipoprotein (HDL) cholesterol', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'non-high-density lipoprotein cholesterol (non-HDL)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Fatty acid pattern in red blood cells', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Fatty acid pattern plasma', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Urea', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Uric acid', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Creatinine', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Glomerular filtration rate (GFR)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Sodium (Na)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Potassium (K)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Chlore (Cl)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Phosphate (P)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Alanine transaminase (ALAT)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Aspartate aminotransferase (ASAT)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Gamma-glutamyl transferase (GGT)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Alkaline phosphatase (ALP)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Lipase', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Haemoglobin', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Mean corpuscular volume (MCV)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Mean corpuscular hemoglobin concentration (MCHC)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Red blood cells', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'White blood cells', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Blood cell count', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Reticulocytes', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Haematocrit', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Body weight', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'Impedancemeter'}, {'measure': 'Waist circumference', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'Measuring tape'}, {'measure': 'Hip circumference', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'Measuring tape'}, {'measure': 'Fat mass', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'Impedancemeter'}, {'measure': 'Lean mass', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'Impedancemeter'}, {'measure': 'Visceral fat mass', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'Impedancemeter'}, {'measure': 'International normalized ratio (INR)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Activated clotting time (ACT)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Iron', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Transferrin', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Ferritin', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': '% transferrin saturation', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Vitamin B12', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': '25-hydroxy-vitamin D', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Protein', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Albumin', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Interleukin-6', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Interleukin-1b', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Tumor necrosis factor alpha (TNFa)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Oxidized low-density lipoprotein (LDLox)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Nitrosylated hemoglobin (HbNO)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'blood samples'}, {'measure': 'Satiety', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'visual analog scale questionnaire'}, {'measure': 'Intestinal tolerance', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'visual analog scale questionnaire'}, {'measure': 'Quality of life 36-item short-form survey (SF36)', 'timeFrame': 'baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)', 'description': 'SF36 questionnaire'}, {'measure': 'Reactive hyperemia index (LnRHI)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'Tonometry'}, {'measure': 'Augmentation index normalized for heart rate (AI@75bpm)', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'Tonometry'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'Tensiometer'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'baseline (visit 1) and Day 90 (last visit 4)', 'description': 'Tensiometer'}, {'measure': 'Glycated haemoglobin (HbA1c)', 'timeFrame': 'Day 30 (visit 2) and Day 60 (visit 3)', 'description': 'Glycated haemoglobin in blood sample'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Abdominal Obesity', 'Sedentary Behavior']}, 'descriptionModule': {'briefSummary': '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.\n\nThis monocentric study is an interventional, randomized, double-blind, control study.', 'detailedDescription': 'n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids show interesting effects in the context of health. Indeed, some studies suggest positive effects on circulating lipids or inflammation associated with certain disorders such as diabetes, following the consumption of these fatty acids.\n\nHowever, these fatty acids are not very present in the classic diet. Therefore, we have developped hens eggs naturally enriched in n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids by changing the hens feed.\n\nThis 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.\n\nTo do this, 80 subjects aged 35 to 75, sedentary (\\<2 hours of physical activity per week) and with abdominal obesity (\\> 94cm for men and\\> 80cm for women) were recruited and were divided into two groups: the control group (12 subjects consuming 2 classic eggs for 3 months per day) or the test group (12 subjects consuming 2 eggs enriched in omega per day for 3 months).\n\nA medical examination with blood sampling was scheduled every month at baseline (Day 0), after one month (Day 30), after two months (Day 60) and at the end of the 3 months of intervention (Day90). During those visits, the following were monitored: glucose parameters, lipids parameters, fatty acid profile of red blood cells and plasma and safety parameters related to haematology, kidney and liver functions .\n\nDuring these monthly medical visits patients also completed the questionnaires assessing intestinal tolerance (visual analogue scale showing 10 gastrointestinal symptoms), satiety (visual analog scale questionnaire) and well-being (36 items short form survey). Eating habits were monitored using a food diary. Additional parameters were measured only during the first and the last visit: coagulation, nutritional status, endothelial function and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman or man, aged of 35 to 75 years\n* Abdominal obesity : waist circumference for men \\> 94cm and \\> 80cm for women\n* Practicing \\< 2h of physical activity per week\n\nExclusion Criteria:\n\n* Uncontrolled systolic blood pressure \\> 160/100mmHg\n* For premenopausal women: pregnant or lactating women\n* For menopausal women: less than 6 months of menopause\n* Perimenopausal women with symptoms\n* Type II diabetes (fasted glycaemia ≥ 126mg/dl or HbA1c ≥ 6.5%), Type I diabetes\n* Medical history or actual cardiovascular disease (myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)\n* 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)\n* Medical history or actual liver, pancreas, kidney, pulmonary or gastrointestinal problem\n* Thyroid disorder\n* Cancer \\< 5 years before the screening visit\n* Smokers or who have stopped smoking within 6 months before the screening visit\n* Subject presenting allergy or food intolerance to eggs\n* Subjects with psychiatric problems and/or using antipsychotics\n* Drug addiction problem\n* Recent change of body weight \\> 5kg (\\< 3 months before the screening visit)\n* Within 3 months before the screening visit, change in the chronic (\\> 7 days in a row) intake or dosage of drug(s) or product(s) modifying\n\n * The glucose or lipid metabolism\n * The blood pressure and heart rate\n * Intestinal tolerance\n * Hepatic, pancreas or kidney functions\n * Satiety\n * The inflammatory status\n* Current or recent (\\< 3 months before the screening visit) intake of dietary supplements rich in n-3 polyunsaturated fatty acid\n* Vegan diet\n* Consumption of fish \\> 3 times per week\n* Subjects who drink more than 3 glasses of alcohol per day (\\> 30 g of alcohol per day)\n* LDL \\> 159 mg/dl or total cholesterol \\> 239 mg/dl or triglyceride \\> 200 mg/dl or HDL \\< 40 mg/dl\n* Docosahexaenoic acid in red blood cell phospholipids \\> 8 %\n* Subjects having participated to another clinical trial \\< 1 month before the screening test visit'}, 'identificationModule': {'nctId': 'NCT04583657', 'acronym': 'Oil4Egg', 'briefTitle': 'Intestinal Tolerance & Health Effects of Daily Consumption of Two Eggs With Fatty Acid Profile Related to Metabolic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'To Evaluate the Intestinal Tolerance and Health Effects of Daily Consumption of Two Eggs With a Particular Fatty Acid Profile on a Set of Parameters Related to Metabolic Disorders', 'orgStudyIdInfo': {'id': 'Oil4Egg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '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%.', 'interventionNames': ['Other: Eggs']}, {'type': 'EXPERIMENTAL', 'label': 'Test', 'description': '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%)', 'interventionNames': ['Other: Eggs']}], 'interventions': [{'name': 'Eggs', 'type': 'OTHER', 'description': 'Consumption of two eggs (control or test) per day during three months', 'armGroupLabels': ['Control', 'Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1348', 'city': 'Louvain-la-Neuve', 'country': 'Belgium', 'facility': 'Center of Investigation in Clinical Nutrition', 'geoPoint': {'lat': 50.66829, 'lon': 4.61443}}], 'overallOfficials': [{'name': 'Yvan Larondelle, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}