Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-31 @ 8:43 AM
Study NCT ID:
NCT05011968
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2021-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007455', 'term': 'Iodine'}], 'ancestors': [{'id': 'D006219', 'term': 'Halogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study were designed by two cohorts The control group and the interventional group. The intervention lasted for 10 days and 100gr of lettuce per day was consumed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2021-07-18', 'studyFirstSubmitQcDate': '2021-08-16', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Thyroid markers', 'timeFrame': '10 days', 'description': 'serum levels of free tri-iodothyronine (FT3 ng/L), free thyroxine (FT4 ng/L) and thyroid-stimulating hormone (TSH ng/L) will be assessed at baseline and after 10 days'}, {'measure': 'Urine Iodine concentration', 'timeFrame': '10 days', 'description': 'Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days'}, {'measure': 'Haematology and serum chemistry values 1', 'timeFrame': '10 days', 'description': 'glucose (mg/dL), albumin( mg/dL), total cholesterol (mg/dL), HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), triglycerides(mg/dL), uric acid(mg/dL), creatinine(mg/dL) will be assessed at baseline and after 10 days'}, {'measure': 'Haematology and serum chemistry values 2', 'timeFrame': '10 days', 'description': 'insulin (mUI/L) will be assessed at baseline and after 10 days'}, {'measure': 'Haematology and serum chemistry values 3', 'timeFrame': '10 days', 'description': 'Potassium (mmol/L) will be assessed at baseline and after 10 days'}, {'measure': 'Haematology and serum chemistry values 4', 'timeFrame': '10 days', 'description': 'Ferritin (mg/L), free Iron (mg/L), transferrin (mg/L), total proteins (mg/L), Magnesium (mg/L), Calcium (mg/L), Vitamin D (mg/L), HCRP (mg/L), Phosphate (mg/L), Cortisol (mg/L)will be assessed at baseline and after 10 days'}, {'measure': 'Haematology and serum chemistry values 5', 'timeFrame': '10 days', 'description': 'AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days'}], 'secondaryOutcomes': [{'measure': 'body mass index (BMI)', 'timeFrame': '10 days', 'description': 'BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days'}, {'measure': 'body composition (%)', 'timeFrame': '10 days', 'description': 'lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days'}, {'measure': 'Gastric Hormones', 'timeFrame': '10 days', 'description': 'GIP (pg/m), GLP1 (pg/m), GLP2 (pg/m), ghrelin (pg/m), glucagon (pg/m), PYY (pg/m), CCK(pg/m) measured in plasma will be assessed at baseline and after 10 days'}, {'measure': 'Oxidative stress markes', 'timeFrame': '10 days', 'description': 'LDL-ox (ug/mL), AGE(ng/mL), urinary 8-iso-prostaglandin F (PGF)2alpha (ng/mL) will be assessed at baseline and after 10 days'}, {'measure': 'Bone metabolism', 'timeFrame': '10 days', 'description': 'Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX, Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days'}, {'measure': 'Inflammatory markers', 'timeFrame': '10 days', 'description': 'IL-1 (pg/mL), TNF(pg/mL), IL-6(pg/mL), IL-10(pg/mL) measured in plasma will be assessed at baseline and after 10 days'}, {'measure': 'Weigh', 'timeFrame': '10 days', 'description': 'Weight (Kg) will be assessed at baseline and after 10 days'}, {'measure': 'Hight', 'timeFrame': '10 days', 'description': 'Hight (m) will be assessed at baseline and after 10 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['functional food', 'biocarrier', 'Iodine'], 'conditions': ['Healthy Individuals']}, 'descriptionModule': {'briefSummary': 'The aim of the project is to study of the influence of Lettuce crop enriched with Iodine on Thyroid hormone synthesis. Secondary outcome to find out iodine presence in urine in order to evaluate vegetables, like little crop, as Iodine biocarrier', 'detailedDescription': 'Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. An alternative or even complementary way is represented by the intake of bio-fortified foods. In the field of mineral deficiency increasing the bioavailable mineral concentration in vegetables intended for human consumption; can be a useful tool to prevent many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.\n\nThe present project aim to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, healthy individuals received lettuce enriched with iodine and after 10 days plasma and urine samples were collected . Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end (after 10 days). The samples thus obtained were transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin,TSH, FT3, FT4, hematocrit, hs-CRP, Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian\n* age: 18-65 years\n* healthy status\n* no drug therapy or integration therapy\n\nExclusion Criteria:\n\n* Inflammatory chronic disease\n* use of medication or suffering from any condition\n* pregnancy\n* breastfeeding\n* current smokers'}, 'identificationModule': {'nctId': 'NCT05011968', 'acronym': 'Nutri-I-Food', 'briefTitle': 'Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Intervention Study With Crop Lettuce Enriched With Iodine', 'orgStudyIdInfo': {'id': 'Nutr-I-Food2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No Intervention: (control group)', 'description': 'The control group was assigned to crop lettuce without any biofortification but with the same characteristic of bioforticated lettuce (soil, water, harvesting time)', 'interventionNames': ['Dietary Supplement: Lettuce with not biofortification']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: intervention group', 'description': 'The intervention group was assigned to biofortificated Iodine crop lettuce.', 'interventionNames': ['Dietary Supplement: Lettuce biofortificated with Iodine']}], 'interventions': [{'name': 'Lettuce with not biofortification', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days', 'armGroupLabels': ['No Intervention: (control group)']}, {'name': 'Lettuce biofortificated with Iodine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days', 'armGroupLabels': ['Experimental: intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90141', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'overallOfficials': [{'name': 'Sonya Vasto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Sonya Vasto', 'investigatorAffiliation': 'University of Palermo'}}}}