Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-03-12 @ 10:43 AM
Study NCT ID:
NCT06032832
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2023-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Absorption From Naturally Dephytinized Legumes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080305', 'term': 'Pork Meat'}], 'ancestors': [{'id': 'D000069466', 'term': 'Red Meat'}, {'id': 'D008460', 'term': 'Meat'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Test meals will be randomized and served to participants. Participants will not know or taste the differences of dephytinization in soy protein concentrate.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized control trial, cross-over'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-09-04', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional iron absorption', 'timeFrame': 'Baseline, 14 days after test meal administration', 'description': 'The fraction of absorbed iron from isotopic iron contained in the test meal. This fractional iron absorption will be measured from blood sample after 14 days from test meal administration'}], 'secondaryOutcomes': [{'measure': 'Iron status', 'timeFrame': 'Baseline, 14 days after test meal administration', 'description': 'Hemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)'}, {'measure': 'Inflammatory status', 'timeFrame': 'Baseline, 14 days after test meal administration', 'description': 'Alpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plant based meat alternative', 'iron absorption', 'soy protein', 'phytic acid', 'dephytinization'], 'conditions': ['Iron Deficiencies']}, 'descriptionModule': {'briefSummary': 'Consumption of less meat and more plant-based protein can greatly reduce the negative impact of food production on the environment. Studies show that vegan diets can decrease greenhouse gas emissions, land use, and water. However, it is important to consider the nutritional value of alternatives, as meat is a key source of nutrients like iron. Iron deficiency anemia (IDA) is estimated to be the top 5 leading causes of years lived with disability burden globally and the first cause in women. Nutritional iron deficiency anemia is often caused by low iron content and low dietary iron bioavailability. As meat, fish, and poultry are excellent sources of bioavailable iron, shifting or maintaining a predominantly plant-based diet can increase the risk of iron deficiency (ID).\n\nPhytic acid, the main phosphorus storage compound in plants, can hinder iron absorption and other divalent minerals. Phytase is an enzyme that breaks down phytic acid, which lessens its ability to bind with minerals like iron. This enzyme is present in various plant tissues, with particularly high amounts found in wheat and rye.\n\nThere is limited clinical evidence regarding iron absorption from plant-based meat. Thus, it is important to measure iron absorption from plant-based foods before and after treatment to remove phytic acid (dephytinization).\n\nThe aim of this study is to determine the effect of phytic acid reduction on iron absorption. FIA of the soy protein concentrates meat analog with phytic acid will be compared with FIA from soy protein concentrate with dephytinization. In addition, this study will assess the FIA in a pork meat meal and will compare it to the FIA from the dephytinized meat analog.', 'detailedDescription': 'The goal of this clinical trial is to assess the iron absorption from plant-based protein with and without the reduction of phytic acid. This study is a randomized control trial, cross-over where each participant acts as their own control.\n\nParticipants will be asked to consume test meals prepared from soy with and without dephytinization and test meals based on minced pork meat, that contains isotopic iron (57Fe and 58Fe) as ferrous sulfate. After 14 days of the test meal administration, participants will be given blood samples to access the isotopic iron enrichment in blood.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women are vulnerable to developing iron deficiency. Thus, this study aims to study in female population according to sex.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged between 18-45 y old\n* Plasma ferritin \\< 30 microgram/L\n* BMI 18.5-25.0\n* Weight \\< 65 kg\n* Signed informed consent\n\nExclusion Criteria:\n\n* Anemic (Hb \\< 12 g/dL)\n* Inflammation (CRP \\> 5 mg/L)\n* Chronic digestive, renal and/or metabolic disease\n* Chronic medications (except for oral contraceptives)\n* Use of vitamin, mineral, and pre-and/or probiotic supplements in the previous 2 weeks and during the study\n* Blood transfusion, blood donation, or significant blood loss (\\> 400 ml) over the past 4 months\n* Difficulty with blood withdrawal\n* Antibiotic treatment in the 4 weeks preceding the start of the study and during the study\n* Pregnancy (tested in serum at screening) or intention to become pregnant during the course of the study\n* Lactation\n* Earlier participation in a study using stable isotopes or participation in any clinical study within the last 30 days\n* Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)\n* Inability to understand the information sheet and the informed consent form due to cognitive or language reasons\n* Smoking\n* celiac disease or gluten intolerance\n* Vegetarian or vegan dietary regimen'}, 'identificationModule': {'nctId': 'NCT06032832', 'acronym': 'LINDA', 'briefTitle': 'Iron Absorption From Naturally Dephytinized Legumes', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Distance University of Applied Sciences'}, 'officialTitle': 'The Effect of Dephytinization on Iron Absorption From a Soy Protein Based Meat Analog, Compared to a Reference Pork Meat Meal: a Randomized Study in Young Women', 'orgStudyIdInfo': {'id': 'Iron_LINDA_2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soy protein concentrate meat analog', 'description': 'Meat analog made from soy protein concentrate contains 57Fe as ferrous sulfate. All participants will consume this test meal.', 'interventionNames': ['Other: soy protein concentrate-meat analog']}, {'type': 'EXPERIMENTAL', 'label': 'Soy protein concentrate meat analog without phytic acid', 'description': 'Meat analog made from soy protein concentrate that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.', 'interventionNames': ['Other: soy protein concentrate-meat analog_dephytinization']}, {'type': 'EXPERIMENTAL', 'label': 'minced pork meat', 'description': 'A meal based on minced pork meat, containing 57Fe intrinsically, will be prepared and served to the participants. All participants will consume this test meal.', 'interventionNames': ['Other: pork meat']}], 'interventions': [{'name': 'soy protein concentrate-meat analog', 'type': 'OTHER', 'description': 'Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate', 'armGroupLabels': ['Soy protein concentrate meat analog']}, {'name': 'soy protein concentrate-meat analog_dephytinization', 'type': 'OTHER', 'description': 'Baked dephytinized\\_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate', 'armGroupLabels': ['Soy protein concentrate meat analog without phytic acid']}, {'name': 'pork meat', 'type': 'OTHER', 'description': 'Meals made with minced pork meat labelled with 57Fe.', 'armGroupLabels': ['minced pork meat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8005', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Diego Moretti, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FFHS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diego Moretti', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr. Diego Moretti', 'investigatorFullName': 'Diego Moretti', 'investigatorAffiliation': 'Swiss Distance University of Applied Sciences'}}}}