Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT07110805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrient And Non-Nutrient Intake, Relative Biomarkers and Their Health Effects In Apparently Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary intake assessment', 'timeFrame': 'At baseline and in 1 month', 'description': 'Two repeated 24h recalls performed at least 3 weeks apart will be used to assess energy, nutrient and non-nutrient intake.'}], 'secondaryOutcomes': [{'measure': 'Anthropometry', 'timeFrame': 'At baseline', 'description': 'Anthropometric measures including weight (in kilograms) and height (in meters) will be measured and combined to report body mass index (BMI) in kg/m\\^2.'}, {'measure': 'Assessment of fat free mass and fat mass', 'timeFrame': 'At baseline', 'description': 'Bio-Impendence Analysis (BIA) was used to assess fat free mass (FFM) in kg and fat mass (FM) in kg.'}, {'measure': 'Bioelectrical phase angle', 'timeFrame': 'At baseline', 'description': 'Bio-Impendence Analysis (BIA) was used to measure phase angle in degree.'}, {'measure': 'MediLite to assess adherence to Mediterranean Diet', 'timeFrame': 'At baseline', 'description': 'The questionnaire consists of 9 items assessing the daily consumption of fruit, vegetables, cereals, meat and meat products, dairy products, alcohol, and olive oil, and the weekly consumption of legumes and fish. Each item provides a score ranging from 0 to 2 points. The final score ranges from 0 (low adherence) to 18 (high adherence to the Mediterranean diet).'}, {'measure': 'MEDAS to assess adherence to Mediterranean Diet', 'timeFrame': 'At baseline', 'description': 'The questionnaire consists of 14 items evaluating the consumption of olive oil for cooking and dressing; daily intake of vegetables, fruits, butter and red meat; weekly intake of wine, legumes, fish, nuts, sweets, pastries or sugar-sweetened beverages; intake of white meat instead of red or processed red meat and the use of "sofrito" sauce. Each item provides a score ranging from 0 to 1 point. The final score ranges from 0 (low adherence) to 14 (high adherence to the Mediterranean diet).'}, {'measure': 'Assessment of physical activity level', 'timeFrame': 'At baseline', 'description': 'The short form of the International Physical Activity Questionnaire (IPAQ) consists of 7 items, exploring the intensity of physical activity based on metabolic equivalent of task (MET) consumption and sedentary behavior.'}, {'measure': 'Assessment of food consumption based on NOVA classification', 'timeFrame': 'At baseline', 'description': 'The NFFQ (NOVA food frequency questionnaire) consists of 94-item grouped in 9 sections headings: (1) fruit and nuts, (2) vegetables and legumes, (3) cereals and tubers, (4) meat and fish, (5) milk, dairy products, and eggs, (6) oils, fats, and seasonings, (7) sweets and sweeteners, (8) beverages and (9) other. Data are reported as g/day and total daily intake for each NOVA category.'}, {'measure': 'Markers of nutritional status', 'timeFrame': 'At baseline', 'description': 'Serum proteins involved in the assessment of nutritional status including albumin in mg/L and transferrin in mg/L as well as serum iron in mg/L will be evaluated through standardized analytical methods.'}, {'measure': 'Fasting glucose and lipid profile', 'timeFrame': 'At baseline', 'description': 'Markers involved in glucose and lipid metabolisms such as fasting glucose in mg/dl, total cholesterol in mg/dl, LDL-cholesterol in mg/dl, HDL-cholesterol in mg/dl and triglycerides in mg/dl will be evaluated in serum through standardized analytical methods.'}, {'measure': 'Liver function', 'timeFrame': 'At baseline', 'description': 'Markers involved in hepatic functions such as aspartate transaminase in U/L, alanine transaminase in U/L and gamma glutamyl transferase in U/L will be evaluated in serum through standardized analytical methods.'}, {'measure': 'Renal function', 'timeFrame': 'At baseline', 'description': 'Markers involved in renal functions including uric acid, azotemia and creatinine in mg/dl will be evaluated in serum through standardized analytical methods.'}, {'measure': 'Vitamins A, E and carotenoids', 'timeFrame': 'At baseline', 'description': 'Plasma vitamin A and vitamin E in µg/mL as well as bioactive compounds such as carotenoids in µg/mL will be evaluated through standardized analytical methods.'}, {'measure': 'Vitamin D', 'timeFrame': 'At baseline', 'description': 'Plasma vitamin D in ng/mL will be evaluated through standardized analytical methods.'}, {'measure': 'Vitamin B12 and folate', 'timeFrame': 'At baseline', 'description': 'Plasma vitamin B12 in ng/mL and folate in ng/mL will be evaluated through standardized analytical methods.'}, {'measure': 'C-reactive protein', 'timeFrame': 'At baseline', 'description': 'C-reactive protein in mg/L will be measured in serum through standardized analytical methods.'}, {'measure': 'Markers of systemic inflammation', 'timeFrame': 'At baseline', 'description': 'Markers involved in the inflammatory status such as TNF-α in pg/mL, IL-6 in pg/mL will be measured in serum through ELISA kits.'}, {'measure': 'Markers of intestinal permeability', 'timeFrame': 'At baseline', 'description': 'Intestinal permeability will be assessed by analyzing serum zonulin in ng/mL and ZO-1 in ng/mL using ELISA kits.'}, {'measure': 'Marker of intestinal permeability', 'timeFrame': 'At baseline', 'description': 'Serum calprotectin in µg/mL and fecal calprotectin in µg/g will be analyzed.'}, {'measure': 'Microbiota composition', 'timeFrame': 'At baseline', 'description': 'Microbiota composition in fecal samples will be evaluated through 16S rRNA sequencing methods.'}, {'measure': 'Proteomic analysis', 'timeFrame': 'At baseline', 'description': 'Proteomic will be performed on serum samples using Somascan.'}, {'measure': 'Metabolomic analysis', 'timeFrame': 'At baseline', 'description': 'Metabolomic will be performed on urine samples by mass spectrometry.'}, {'measure': 'Cellular DNA damage', 'timeFrame': 'At baseline', 'description': 'To assess damage at the cellular DNA level the Comet assay technique will be employed.'}]}, 'conditionsModule': {'conditions': ['Participants With/Without Risk Factors for Metabolic Diseases']}, 'descriptionModule': {'briefSummary': 'This observational study aims to provide a comprehensive evaluation of dietary habits, physical activity, biomarkers involved in nutrition, metabolic and inflammatory status as well as intestinal permeability in apparently healthy volunteers aged over 18 years working or studying at the University of Milan. Furthermore, the analysis of the gut microbiota composition along with the omics approaches will be crucial for a better comprehension of the relationship between diet and health status in this population. As part of the OnFoods project (Project code PE00000003, Concession Decree No. 1550 of 11 October 2022 adopted by the Italian Ministry of University and Research, CUP D93C22000890001, Project title "ON Foods - Research and innovation network on food and nutrition Sustainability, Safety and Security - Working ON Foods"), the results will be valuable for suggesting targeted dietary and behavioral guidance in the context of public health policies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Both workers and students of the University of Milan aged over 18 years old volunteer to participate by responding to calls for study participation (e.g., a flyer or emails).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy volunteers\n* age ≥ 18 years old\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* not willing to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07110805', 'acronym': 'NUTRI-BRIDGE', 'briefTitle': 'Nutrient And Non-Nutrient Intake, Relative Biomarkers and Their Health Effects In Apparently Healthy Participants', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Nutrient And Non-Nutrient Intake, Relative Biomarkers And Their Health Impact In Different Target Populations - The NUTRIPOP-BRIDGE Study', 'orgStudyIdInfo': {'id': '110/23'}}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Division of Human Nutrition Department of Food, Environmental and Nutritional Sciences - DeFENS Università degli Studi di Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': "Prof. Del Bo' Cristian", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}, {'name': 'Prof. Riso Patrizia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}, {'name': 'Prof. Martini Daniela', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}, {'name': 'Dr. Cioffi Iolanda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}, {'name': 'Dr. Marino Mirko', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Iolanda Cioffi', 'investigatorAffiliation': 'University of Milan'}}}}