Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT05614960
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2022-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dried Purple Laver (Nori) as a Food Source of Vitamin B12 in Vegetarians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}], 'ancestors': [{'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in holotranscobalamin in 4 weeks', 'timeFrame': '4 weeks (Week 4 - Baseline)', 'description': 'Assessing the change in serum holotranscobalamin after consuming varying doses of nori'}, {'measure': 'Change in methylmalonic acid in 4 weeks', 'timeFrame': '4 weeks (Week 4 - Baseline)', 'description': 'Assessing the change in serum methylmalonic acid after consuming varying doses of nori'}], 'secondaryOutcomes': [{'measure': 'Change in serum vitamin B12 concentration in 4 weeks', 'timeFrame': '4 weeks (Week 4 - Baseline)', 'description': 'Assessing the change in serum vitamin B12 after consuming varying doses of nori'}, {'measure': 'Change in homocysteine in 4 weeks', 'timeFrame': '4 weeks (Week 4 - Baseline)', 'description': 'Assessing the change in serum homocysteine after consuming varying doses of nori'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin B12', 'Vegetarian diet', 'Purple laver (Porphyra sp.)', 'Nori'], 'conditions': ['Vitamin B 12 Deficiency']}, 'referencesModule': {'references': [{'pmid': '35399690', 'type': 'BACKGROUND', 'citation': 'Chiu THT, Kao YC, Wang LY, Chang HR, Lin CL. A Dietitian-Led Vegan Program May Improve GlycA, and Other Novel and Traditional Cardiometabolic Risk Factors in Patients With Dyslipidemia: A Pilot Study. Front Nutr. 2022 Mar 24;9:807810. doi: 10.3389/fnut.2022.807810. eCollection 2022.'}, {'pmid': '11430774', 'type': 'BACKGROUND', 'citation': 'Takenaka S, Sugiyama S, Ebara S, Miyamoto E, Abe K, Tamura Y, Watanabe F, Tsuyama S, Nakano Y. Feeding dried purple laver (nori) to vitamin B12-deficient rats significantly improves vitamin B12 status. Br J Nutr. 2001 Jun;85(6):699-703. doi: 10.1079/bjn2001352.'}, {'pmid': '8926531', 'type': 'BACKGROUND', 'citation': 'Suzuki H. Serum vitamin B12 levels in young vegans who eat brown rice. J Nutr Sci Vitaminol (Tokyo). 1995 Dec;41(6):587-94. doi: 10.3177/jnsv.41.587.'}, {'pmid': '25651739', 'type': 'BACKGROUND', 'citation': 'Schwarz J, Dschietzig T, Schwarz J, Dura A, Nelle E, Watanabe F, Wintgens KF, Reich M, Armbruster FP. The influence of a whole food vegan diet with Nori algae and wild mushrooms on selected blood parameters. Clin Lab. 2014;60(12):2039-50. doi: 10.7754/clin.lab.2014.140527.'}, {'pmid': '7562085', 'type': 'BACKGROUND', 'citation': 'Rauma AL, Torronen R, Hanninen O, Mykkanen H. Vitamin B-12 status of long-term adherents of a strict uncooked vegan diet ("living food diet") is compromised. J Nutr. 1995 Oct;125(10):2511-5. doi: 10.1093/jn/125.10.2511.'}, {'pmid': '24803097', 'type': 'BACKGROUND', 'citation': 'Watanabe F, Yabuta Y, Bito T, Teng F. Vitamin B(1)(2)-containing plant food sources for vegetarians. Nutrients. 2014 May 5;6(5):1861-73. doi: 10.3390/nu6051861.'}, {'pmid': '27916823', 'type': 'BACKGROUND', 'citation': 'Rizzo G, Lagana AS, Rapisarda AM, La Ferrera GM, Buscema M, Rossetti P, Nigro A, Muscia V, Valenti G, Sapia F, Sarpietro G, Zigarelli M, Vitale SG. Vitamin B12 among Vegetarians: Status, Assessment and Supplementation. Nutrients. 2016 Nov 29;8(12):767. doi: 10.3390/nu8120767.'}, {'pmid': '39352476', 'type': 'DERIVED', 'citation': 'Huang QN, Watanabe F, Koseki K, He RE, Lee HL, Chiu THT. Effect of roasted purple laver (nori) on vitamin B12 nutritional status of vegetarians: a dose-response trial. Eur J Nutr. 2024 Dec;63(8):3269-3279. doi: 10.1007/s00394-024-03505-9. Epub 2024 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'This is an intervention study aiming to understand the bioavailability of vitamin B12 from nori for vegetarians.', 'detailedDescription': 'Thirty vegetarian participants will be randomly assigned to one of three intervention arms: (1) 5g of nori (4 sheets, containing 2.4μg vitamin B12), (2) 8g nori (7 sheets, containing 4μg vitamin B12), (3) control group (no nori). At baseline and end of 4 weeks, participants will be measured on serum vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine and folate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vegetarians (including vegan, ovo-vegetarian, lacto-vegetarian, lacto-ovo vegetarian)\n* Duration of the vegetarian diet: at least 1 year\n* Aged 20-60 years old\n* Have not taken vitamin B12 or folate supplement within 1 year\n* Willing to adhere to study intervention and be tested for vitamin B12 related biomarkers.\n* Familiar with LINE application on smartphone\n\nExclusion Criteria:\n\n* Any disease or surgery that affects the vitamin B12 status (Pernicious anemia, Gastrointestinal disease and surgery, Pancreatic diseases, Chronic kidney disease)\n* Hyperthyroidism\n* Previous adverse reaction to nori\n* Have taken antacid or metformin in the past 1 week\n* Alcoholic and not willing to abstinence from alcoholic beverages'}, 'identificationModule': {'nctId': 'NCT05614960', 'briefTitle': 'Dried Purple Laver (Nori) as a Food Source of Vitamin B12 in Vegetarians', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'The Bioavailability of Vitamin B12 From Nori in Vegetarians: a Dose Response Study', 'orgStudyIdInfo': {'id': 'FuJenCU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2.4μg vitamin B12', 'description': 'Participants need to consume 4 sheets (5g) of dried purple laver (Nori) daily for 4 weeks.', 'interventionNames': ['Other: Dried purple laver (Nori)']}, {'type': 'EXPERIMENTAL', 'label': '4μg vitamin B12', 'description': 'Participants need to consume 7 sheets (8g) of dried purple laver (Nori) daily for 4 weeks.', 'interventionNames': ['Other: Dried purple laver (Nori)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Dried purple laver (Nori)', 'type': 'OTHER', 'description': 'Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.', 'armGroupLabels': ['2.4μg vitamin B12', '4μg vitamin B12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24205', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Department of Nutritional Science, Fu-Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'Tina Hsueh-Ting Chiu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu-Jen Catholic University, Department of Nutritional Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tina Hsueh-Ting Chiu', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}