Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-30 @ 2:06 AM
Study NCT ID:
NCT05783466
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dairy Lipids and Cardiometabolic Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}], 'ancestors': [{'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': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total plasma apolipoprotein B concentration', 'timeFrame': 'day 0 and day 90', 'description': 'Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.'}], 'secondaryOutcomes': [{'measure': 'Changes in weight', 'timeFrame': 'day 0 and day 90', 'description': 'Changes in weight after 3-month intervention.'}, {'measure': 'Anthropometric measurements 2', 'timeFrame': 'day 0 and day 90', 'description': 'Changes in waist and hip circumferences after 3-month intervention.'}, {'measure': 'Body mass composition measurements', 'timeFrame': 'day 0 and day 90', 'description': 'Change in body mass composition (lean mass, fat mass) after 3-month intervention, analyzed by impedancemeter'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. • For postprandial measurements: times 60 minutes-120 minutes -180 minutes -240 minutes -270 minutes -300 minutes -360 minutes', 'description': 'Changes in plasma concentrations of triglycerides'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -180 minutes -240 minutes -270 minutes -300 minutes.', 'description': 'Changes in plasma concentrations of total cholesterol'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.', 'description': 'Changes in plasma concentrations of LDL-cholesterol'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.', 'description': 'Changes in plasma concentrations of HDL-cholesterol'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes.', 'description': 'Changes in plasma concentrations of apoB100'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes - 360 minutes', 'description': 'Changes in plasma concentrations of apoB48'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes.', 'description': 'Changes in plasma concentrations of apoA1'}, {'measure': 'Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes', 'description': 'Changes in plasma concentrations of unesterified fatty acids'}, {'measure': 'Glucose concentrations after 3-month intervention, measured using standard laboratory methods', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes', 'description': 'Changes in plasma concentrations of glucose'}, {'measure': 'Glucose concentrations after 3-month intervention, measured using standard laboratory methods 2', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes', 'description': 'Changes in plasma concentrations of insulin'}, {'measure': 'Targeted plasma lipidomics after 3-month intervention', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in plasma concentrations of phospholipids'}, {'measure': 'Targeted plasma lipidomics after 3-month intervention 2', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in plasma concentrations of sphingolipids (sphingomyelins and ceramides)'}, {'measure': 'Targeted plasma lipidomics after 3-month intervention 3', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in plasma concentrations of lysophospholipids'}, {'measure': 'Targeted plasma lipidomics after 3-month intervention 4', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in plasma concentrations of fatty acids in plasma total lipids'}, {'measure': 'Targeted plasma lipidomics after 3-month intervention 5', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in plasma concentrations of phospholipids'}, {'measure': 'Targeted chylomicrons of plasma after 3-month intervention', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in concentrations of triglycerides'}, {'measure': 'Targeted chylomicrons of plasma after 3-month intervention 2', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in concentrations of cholesterol'}, {'measure': 'Targeted chylomicrons of plasma after 3-month intervention 3', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in concentrations of sphingolipids'}, {'measure': 'Targeted chylomicrons of plasma after 3-month intervention 4', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.', 'description': 'Changes in concentrations of fatty acids'}, {'measure': 'Inflammation markers', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements.', 'description': 'Changes in adiponectin'}, {'measure': 'Inflammation markers 2', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements.', 'description': 'Changes in CRP'}, {'measure': 'Inflammation markers 3', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements.', 'description': 'Changes in cytokines'}, {'measure': 'Inflammation markers 4', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements.', 'description': 'Changes in LBP'}, {'measure': 'Inflammation markers 5', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements.', 'description': 'Changes in endotoxins'}, {'measure': 'Inflammation markers 6', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements.', 'description': 'Changes in CD14'}, {'measure': 'Inflammation markers 7', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements.', 'description': 'Gene expressions of inflammation markers after 3-month intervention, measured with dedicated kits and PAXgene kit'}, {'measure': 'Platelet activation markers', 'timeFrame': 'day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements,times 120 minutes-240 minutes-300 minutes -360 minutes.', 'description': 'Changes in thromboxane B2 concentrations in platelets (from blood donors) stimulated by lipoproteins (chylomicrons and HDL) after 3-month intervention, measured with an ELISA kit.\n\nDifferences in the percents of aggregation of platelets incubated with lipoproteins (chylomicrons and HDL) after 3-month intervention, assessed by light transmission aggregometry.'}, {'measure': 'Oxidative stress marker', 'timeFrame': 'day 0 and day 90', 'description': 'Changes in urinary concentrations of 8-iso-PGF2 alpha isoprostane after 3-month intervention, determined with an ELISA kit'}, {'measure': 'Markers of immune cells', 'timeFrame': 'day 0 and day 90', 'description': 'PBMC'}, {'measure': 'Markers of immune cells 2', 'timeFrame': 'day 0 and day 90', 'description': 'Complete blood counts'}, {'measure': 'Intestinal microbiota after 3-month intervention.', 'timeFrame': 'day 0 and day 90', 'description': 'Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)'}, {'measure': 'Intestinal microbiota after 3-month intervention 2', 'timeFrame': 'day 0 and day 90', 'description': 'Changes in fecal concentrations of microbiota-derived metabolites (coprostanol, short chain fatty acids (SCFA), calprotectin)'}, {'measure': 'Questionnaires on physical activity', 'timeFrame': 'day 0 and day 90', 'description': 'International Physical Activity Questionnaire (\\[i\\] ëinactive, \\[ii\\] ëminimally active, \\[iii\\] ëHEPA activeí (health enhancing physical activity; a high active category).)'}, {'measure': 'Questionnaires on digestive comfort', 'timeFrame': 'day 0 and day 90', 'description': 'Liker scale'}, {'measure': 'Questionnaires on digestive comfort', 'timeFrame': 'day 0 and day 90', 'description': 'Bristol stool scale'}, {'measure': 'Questionnaires on product satiety', 'timeFrame': 'day 0 and day 90', 'description': 'Satiety from visual analog scale (VAS)'}, {'measure': 'Questionnaires food intake', 'timeFrame': 'day 0 and day 90', 'description': 'Three-factor eating questionnaire (TFEQ)'}, {'measure': 'Questionnaires on product appreciation', 'timeFrame': 'day 0 and day 90', 'description': 'Product appreciation questionnaire'}, {'measure': 'Dietary intake questionnaire', 'timeFrame': 'day 0 and day 90', 'description': 'Dietary record questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Nutrition', 'Dietary intervention', 'Weight loss', 'Metabolism', 'Dairy', 'Fat', 'Milk polar lipids'], 'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group).\n\nMetabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women between 18-70 years\n* Body Mass Index (BMI) between 35 and 60 kg/m2 inclusive\n* Stable body weight (weight change +/- 5 % for 3 months prior to screening)\n* Consumption of at least 1 serving/day of dairy products made from cow's milk\n* Informed consent\n\nExclusion Criteria:\n\n* History of bariatric or digestive surgery or disease interfering with main outcomes\n* Drinking more than 3 glasses of alcohol per day (\\>30g/day)\n* Pregnancy, parturiency or breastfeeding\n* Food allergies or intolerance to dairy products\n* Dietary restriction (vegetarian or lactovegetarian) or high protein diet\n* Use of dietary supplements\n* Treated with lipid lowering drugs (fibrates, statins, anti-PCSK9, ezetimibe, cholestyramine) within the last 6 weeks before study entry\n* Treated with insulin, GLP-1 analogs, acarbose, corticoids, beta-blockers.\n* Medications interfering with intestinal microbiota (beta-lactamines within 3 months before the study or laxatives)\n* Smoking ≥ 5 cigarettes/day during the past 6 months."}, 'identificationModule': {'nctId': 'NCT05783466', 'acronym': 'DAILICATE', 'briefTitle': 'Dairy Lipids and Cardiometabolic Risk', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity', 'orgStudyIdInfo': {'id': '69HCL22_0461'}, 'secondaryIdInfos': [{'id': '2022-A02415-38', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low-fat dairy products within a dietary handling for weight loss', 'description': '3 servings/day of low-fat dairy products: 1 serving of low-fat cheese, 1 serving of low-fat yogurt and 1 serving of (semi-)skimmed milk.', 'interventionNames': ['Other: Low-fat dairy products']}, {'type': 'EXPERIMENTAL', 'label': 'Whole-fat dairy products within a dietary handling for weight loss', 'description': '3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.', 'interventionNames': ['Other: Whole-fat dairy products']}, {'type': 'EXPERIMENTAL', 'label': 'Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss', 'description': '3 servings/day of whole-fat dairy products (1 milk, 1 yogurt, 1 cheese) among which 1 serving/day is enriched with milk polar lipids via butterier.', 'interventionNames': ['Other: Milk polar lipid enriched whole-fat dairy products']}], 'interventions': [{'name': 'Low-fat dairy products', 'type': 'OTHER', 'description': '3-month intervention', 'armGroupLabels': ['Low-fat dairy products within a dietary handling for weight loss']}, {'name': 'Whole-fat dairy products', 'type': 'OTHER', 'description': '3-month intervention', 'armGroupLabels': ['Whole-fat dairy products within a dietary handling for weight loss']}, {'name': 'Milk polar lipid enriched whole-fat dairy products', 'type': 'OTHER', 'description': '3-month intervention', 'armGroupLabels': ['Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel DISSE, Pr', 'role': 'CONTACT', 'email': 'emmanuel.disse@chu-lyon.fr', 'phone': '+33 4 78 86 14 89'}, {'name': 'SEGRESTIN Bérénice, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'RAJOT Amélie, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'CAUSSY Cyrielle, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition", 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Emmanuel DISSE, Pr', 'role': 'CONTACT', 'email': 'emmanuel.disse@chu-lyon.fr', 'phone': '+33 4 78 86 14 89'}, {'name': 'MArie-Caroline MICHALSKI, Dr', 'role': 'CONTACT', 'email': 'marie-caroline.michalski@inrae.fr', 'phone': '+33 4 26 23 61 71'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition', 'class': 'UNKNOWN'}, {'name': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe', 'class': 'OTHER'}, {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}