Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-01 @ 6:22 PM
Study NCT ID:
NCT02099032
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2014-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total plasma cholesterol', 'timeFrame': 'Day 0 and Day 28', 'description': 'Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.'}], 'secondaryOutcomes': [{'measure': 'Plasma lipids', 'timeFrame': 'Day 0 and Day 28', 'description': 'Plasma lipids will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters (time 60-120-180-240-270-300-360-420-480 minutes)'}, {'measure': 'Plasma glucose and insulin', 'timeFrame': 'Day 0 and Day 28', 'description': 'Plasma glucose and insulin will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours.'}, {'measure': 'Inflammatory markers', 'timeFrame': 'Day 0 and Day 28', 'description': 'Inflammatory markers will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters'}, {'measure': 'Body composition measurement with bioimpedancemetry', 'timeFrame': 'Day 0 and Day 28', 'description': 'Body composition will be measured fasting before and after the four weeks of cheese product intake.'}, {'measure': 'Energy expenditure and substrate oxidation with indirect calorimetry', 'timeFrame': 'Day 0 and Day 28', 'description': 'Energy metabolism will be measured before and after the four weeks of cheese product intake. Fasting and during all the postprandial period (480 minutes)'}, {'measure': 'Intestinal microbiota with molecular approach', 'timeFrame': 'before and after the four weeks of cheese product intake', 'description': 'Stools will be collected at home before and after the four weeks of cheese product intake.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nutrition', 'milk', 'polar lipids', 'cardiometabolic risk'], 'conditions': ['Cardiometabolic Risk']}, 'referencesModule': {'references': [{'pmid': '33857018', 'type': 'DERIVED', 'citation': 'Le Barz M, Vors C, Combe E, Joumard-Cubizolles L, Lecomte M, Joffre F, Trauchessec M, Pesenti S, Loizon E, Breyton AE, Meugnier E, Bertrand K, Drai J, Robert C, Durand A, Cuerq C, Gaborit P, Leconte N, Bernalier-Donadille A, Cotte E, Laville M, Lambert-Porcheron S, Ouchchane L, Vidal H, Malpuech-Brugere C, Cheillan D, Michalski MC. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women. JCI Insight. 2021 May 24;6(10):e146161. doi: 10.1172/jci.insight.146161.'}, {'pmid': '31189655', 'type': 'DERIVED', 'citation': 'Vors C, Joumard-Cubizolles L, Lecomte M, Combe E, Ouchchane L, Drai J, Raynal K, Joffre F, Meiller L, Le Barz M, Gaborit P, Caille A, Sothier M, Domingues-Faria C, Blot A, Wauquier A, Blond E, Sauvinet V, Gesan-Guiziou G, Bodin JP, Moulin P, Cheillan D, Vidal H, Morio B, Cotte E, Morel-Laporte F, Laville M, Bernalier-Donadille A, Lambert-Porcheron S, Malpuech-Brugere C, Michalski MC. Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay. Gut. 2020 Mar;69(3):487-501. doi: 10.1136/gutjnl-2018-318155. Epub 2019 Jun 12.'}], 'seeAlsoLinks': [{'url': 'http://www.crnh-rhone-alpes.fr', 'label': 'Related Info'}, {'url': 'http://www1.clermont.inra.fr/crnh/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.\n\nPolar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids.\n\nThe purpose of this research is to study plasma cholesterol variation after daily intake of milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of cheese product during four weeks instead of their usual cheese products.\n\nIt is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Menopausal women\n* Of less than 75 years old- Body Mass Index of 25 to 35 kg/m2\n* Waist circumference greater than 80 cm\n* Normal (or not clinically significant) glycemic and lipid parameters\n\nExclusion Criteria:\n\n* Dairy products allergy or intolerance\n* Smokers (more than five cigarettes/day)\n* HDL cholesterol greater than 1.5 mmol/L\n* Medication that could interfere with lipid metabolism or intestinal microbiota (for example, no antibiotics within the 2 months before the study)\n* Hormone replacement treatment for menopause'}, 'identificationModule': {'nctId': 'NCT02099032', 'acronym': 'VALOBAB-C', 'briefTitle': 'Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women', 'orgStudyIdInfo': {'id': '2013.821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3g milk polar lipid fortified cheese product', 'description': 'Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.', 'interventionNames': ['Other: 3g milk polar lipid fortified cheese consumption']}, {'type': 'EXPERIMENTAL', 'label': '5 g milk polar lipid fortified cheese product', 'description': 'Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.', 'interventionNames': ['Other: 5g milk polar lipid fortified cheese consumption']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Unfortified cheese product', 'description': 'Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks', 'interventionNames': ['Other: Unfortified cheese product consumption']}], 'interventions': [{'name': '3g milk polar lipid fortified cheese consumption', 'type': 'OTHER', 'description': 'Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.', 'armGroupLabels': ['3g milk polar lipid fortified cheese product']}, {'name': '5g milk polar lipid fortified cheese consumption', 'type': 'OTHER', 'description': 'Women will have to consume daily 100g of a 5 g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.', 'armGroupLabels': ['5 g milk polar lipid fortified cheese product']}, {'name': 'Unfortified cheese product consumption', 'type': 'OTHER', 'description': 'Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks', 'armGroupLabels': ['Unfortified cheese product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63001', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': "Université d'Auvergne-Laboratoire de Nutrition Humaine", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}