Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-03 @ 11:32 PM
Study NCT ID:
NCT06491095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Flax in Yogurt on Blood Cyanide Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008043', 'term': 'Linseed Oil'}], 'ancestors': [{'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Concentration of metabolites in blood and urine', 'timeFrame': '180 minutes', 'description': 'Identification and concentration of metabolites in plasma and urine determined by LC-QTOF-MS'}], 'primaryOutcomes': [{'measure': 'Peak blood level of cyanide', 'timeFrame': '180 minutes', 'description': 'highest concentration of cyanide during 180 min postprandial period'}, {'measure': 'iAUC blood cyanide', 'timeFrame': '180 min', 'description': 'incremental area under the curve for cyanide from 0-180 min'}], 'secondaryOutcomes': [{'measure': 'Cyanogenic glycoside and thiocyanate concentrations in plasma and urine', 'timeFrame': '180 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flax', 'Blood Cyanide'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25708890', 'type': 'BACKGROUND', 'citation': 'Abraham K, Buhrke T, Lampen A. Bioavailability of cyanide after consumption of a single meal of foods containing high levels of cyanogenic glycosides: a crossover study in humans. Arch Toxicol. 2016 Mar;90(3):559-74. doi: 10.1007/s00204-015-1479-8. Epub 2015 Feb 24.'}, {'type': 'BACKGROUND', 'citation': 'Agbor-Egbe T, Lape Mbome I. The effects of processing techniques in reducing cyanogen levels during the production of some Cameroonian cassava foods. Journal of Food Composition and Analysis. 2006 Jun;19(4):354-63.'}, {'pmid': '10418947', 'type': 'BACKGROUND', 'citation': 'Carlsson L, Mlingi N, Juma A, Ronquist G, Rosling H. Metabolic fates in humans of linamarin in cassava flour ingested as stiff porridge. Food Chem Toxicol. 1999 Apr;37(4):307-12. doi: 10.1016/s0278-6915(99)00015-0.'}, {'pmid': '30615957', 'type': 'BACKGROUND', 'citation': 'Cressey P, Reeve J. Metabolism of cyanogenic glycosides: A review. Food Chem Toxicol. 2019 Mar;125:225-232. doi: 10.1016/j.fct.2019.01.002. Epub 2019 Jan 4.'}, {'type': 'BACKGROUND', 'citation': 'Cressey P, Saunders D, Aupaau F. Evaluation of food safety risks associated with foods containing cyanogenic glycosides. New Zealand Food Safety Technical Paper No: 2022/29. 2022 Nov.'}, {'pmid': '37586035', 'type': 'BACKGROUND', 'citation': 'Diaz-Rueda P, Morales de Los Rios L, Romero LC, Garcia I. Old poisons, new signaling molecules: the case of hydrogen cyanide. J Exp Bot. 2023 Oct 13;74(19):6040-6051. doi: 10.1093/jxb/erad317.'}, {'pmid': '32626287', 'type': 'BACKGROUND', 'citation': 'EFSA Panel on Contaminants in the Food Chain (CONTAM); Schrenk D, Bignami M, Bodin L, Chipman JK, Del Mazo J, Grasl-Kraupp B, Hogstrand C, Hoogenboom LR, Leblanc JC, Nebbia CS, Nielsen E, Ntzani E, Petersen A, Sand S, Vleminckx C, Wallace H, Benford D, Brimer L, Mancini FR, Metzler M, Viviani B, Altieri A, Arcella D, Steinkellner H, Schwerdtle T. Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels. EFSA J. 2019 Apr 11;17(4):e05662. doi: 10.2903/j.efsa.2019.5662. eCollection 2019 Apr.'}, {'pmid': '24579992', 'type': 'BACKGROUND', 'citation': 'Gleadow RM, Moller BL. Cyanogenic glycosides: synthesis, physiology, and phenotypic plasticity. Annu Rev Plant Biol. 2014;65:155-85. doi: 10.1146/annurev-arplant-050213-040027. Epub 2014 Feb 24.'}, {'type': 'BACKGROUND', 'citation': 'Joint FAO/WHO Expert Committee on Food Additives (JECFA). Safety evaluation of certain food additives and contaminants. WHO food additives series; 65. 2012'}, {'type': 'BACKGROUND', 'citation': 'Mazza G and Oomah BD. Flaxseed, dietary fiber, and cyanogens. In: "Flaxseed in human nutrition", Editors: Cunnane, S.C. and Thompson, L.U., AOCS Press, 1995 56-81.'}, {'pmid': '10995312', 'type': 'BACKGROUND', 'citation': 'Muir AD, Westcott ND. Quantitation of the lignan secoisolariciresinol diglucoside in baked goods containing flax seed or flax meal. J Agric Food Chem. 2000 Sep;48(9):4048-52. doi: 10.1021/jf990922p.'}, {'pmid': '12842188', 'type': 'BACKGROUND', 'citation': 'Ngudi DD, Kuo YH, Lambein F. Cassava cyanogens and free amino acids in raw and cooked leaves. Food Chem Toxicol. 2003 Aug;41(8):1193-7. doi: 10.1016/s0278-6915(03)00111-x.'}, {'pmid': '29101172', 'type': 'BACKGROUND', 'citation': 'Parikh M, Netticadan T, Pierce GN. Flaxseed: its bioactive components and their cardiovascular benefits. Am J Physiol Heart Circ Physiol. 2018 Feb 1;314(2):H146-H159. doi: 10.1152/ajpheart.00400.2017. Epub 2017 Nov 3.'}, {'pmid': '33573160', 'type': 'BACKGROUND', 'citation': 'Yulvianti M, Zidorn C. Chemical Diversity of Plant Cyanogenic Glycosides: An Overview of Reported Natural Products. Molecules. 2021 Jan 30;26(3):719. doi: 10.3390/molecules26030719.'}], 'seeAlsoLinks': [{'url': 'https://www.mpi.govt.nz/dmsdocument/25688/direct', 'label': 'New Zealand Food Safety Authority. Cyanogenic glycosides -Information sheet.'}, {'url': 'https://doi.org/10.1016/j.toxlet.2014.06.582', 'label': 'Schneider B. Activity of β-glucosidase in plants with high content of cyanogenic glycosides as important factor determining their toxicity. Toxicology Letters. 2014 229, S170-S170'}]}, 'descriptionModule': {'briefSummary': 'A randomized, controlled, cross-over post-prandial trial in healthy human volunteers will be conducted at the IH Asper Institute to determine the effect whole ground flaxseed, roasted then ground whole flaxseed, whole intact flaxseed and flaxseed hulls mixed into yogurt on blood cyanide levels.', 'detailedDescription': 'Participants will receive yogurt containing the following flaxseed products in a random order:\n\n1. 40 g ground flaxseed, untreated;\n2. 40 g ground flaxseed, roasted before grinding;\n3. 40 g intact whole flaxseed;\n4. 28 g flaxseed hulls;\n5. 0 g flaxseed.\n\nVenous blood will be collected at the following time points: 0 (before consumption of test product), 15, 30, 45, 60, 75, 90, 120, 150, 180 min.\n\nUrine will be collected prior to consumption of test product and 180 min.\n\nPrimary endpoints: 1) Peak blood level of cyanide and incremental area under the curve (iAUC) for cyanide in blood over a 3h postprandial period. Secondary endpoint: 1) cyanogenic glycoside and thiocyanate concentrations in plasma and urine over a 3h postprandial period.\n\nTertiary endpoints: 1) metabolic profile in plasma and urine over 3 h postprandial period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Generally healthy adult, 18 years or older;\n2. Willing to provide informed consent;\n3. Willing/able to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating;\n2. Medical history of disease that is currently under treatment;\n3. Active treatment for any type of cancer within 1 year prior to study start;\n4. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks;\n5. Plasma concentration of vitamin B12 \\< 148 pmol/L;\n6. Complete blood count outside normal range;\n7. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥3 times the upper limit of normal (ULN));\n8. Fasting blood glucose ≥6.1 mmol/L and/or HbA1c ≥6.0%;\n9. Fasting plasma total cholesterol \\>7.8 mmol/L;\n10. Fasting plasma HDL \\<0.9 mmol/L;\n11. Fasting plasma LDL \\>5.0 mmol/L;\n12. Fasting plasma triglycerides \\>2.3 mmol/L;\n13. Systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg;\n14. Major surgery within the last 3 months;\n15. Smoking, use of tobacco, vape or cannabis (within the last week);\n16. Allergies to flaxseed or yogurt;\n17. Aversion or unwillingness to eat study foods;\n18. Participation in another clinical trial, current or in the past 4 weeks'}, 'identificationModule': {'nctId': 'NCT06491095', 'briefTitle': 'Effect of Flax in Yogurt on Blood Cyanide Levels', 'organization': {'class': 'OTHER', 'fullName': 'St. Boniface Hospital'}, 'officialTitle': 'A Randomized, Controlled, Cross-over Trial Examining the Effect of Flaxseed on Blood Cyanide Levels in Healthy Adults', 'orgStudyIdInfo': {'id': '4030/4687'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'No Flax Product', 'description': '175 g yogurt containing no flax product', 'interventionNames': ['Dietary Supplement: 0 g Flax']}, {'type': 'EXPERIMENTAL', 'label': '40 g whole ground flaxseed', 'description': '175 g yogurt with 40 g whole ground flaxseed', 'interventionNames': ['Dietary Supplement: 40 g whole ground flaxseed']}, {'type': 'EXPERIMENTAL', 'label': '40 g roasted then ground whole flaxseed', 'description': '175 g yogurt with 40 g roasted then ground whole flaxseed', 'interventionNames': ['Dietary Supplement: 40 g roasted then ground whole flaxseed']}, {'type': 'EXPERIMENTAL', 'label': '40 g of whole intact flaxseeds', 'description': '175 g yogurt with 40 g of whole intact flaxseeds', 'interventionNames': ['Dietary Supplement: 40 g of whole intact flaxseeds']}, {'type': 'EXPERIMENTAL', 'label': '28 g flax hulls', 'description': '175 g yogurt with 28 g flax hulls', 'interventionNames': ['Dietary Supplement: 28 g flax hulls']}], 'interventions': [{'name': '0 g Flax', 'type': 'DIETARY_SUPPLEMENT', 'description': '175 g yogurt with no flax product', 'armGroupLabels': ['No Flax Product']}, {'name': '40 g whole ground flaxseed', 'type': 'DIETARY_SUPPLEMENT', 'description': '175 g yogurt with 40 g whole ground flaxseed', 'armGroupLabels': ['40 g whole ground flaxseed']}, {'name': '40 g roasted then ground whole flaxseed', 'type': 'DIETARY_SUPPLEMENT', 'description': '175 g yogurt with 40 g roasted then ground whole flaxseed', 'armGroupLabels': ['40 g roasted then ground whole flaxseed']}, {'name': '40 g of whole intact flaxseeds', 'type': 'DIETARY_SUPPLEMENT', 'description': '175 g yogurt with 40 g of whole intact flaxseeds', 'armGroupLabels': ['40 g of whole intact flaxseeds']}, {'name': '28 g flax hulls', 'type': 'DIETARY_SUPPLEMENT', 'description': '175 g yogurt with 28 g flax hulls', 'armGroupLabels': ['28 g flax hulls']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'contacts': [{'name': 'Heather J Blewett, PhD', 'role': 'CONTACT', 'email': 'hblewett@sbrc.ca', 'phone': '204-237-2954'}, {'name': 'Heather J Blewett, PhD', 'role': 'CONTACT'}, {'name': 'Véronique J Barthet, PhD', 'role': 'CONTACT'}, {'name': 'Michel Aliani, PhD', 'role': 'CONTACT'}, {'name': 'Lovemore Malunga, PhD', 'role': 'CONTACT'}], 'facility': 'I. H. Asper Clinical Research Institute', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Heather Blewett, PhD', 'role': 'CONTACT', 'email': 'hblewett@sbrc.ca', 'phone': '204-237-2954'}], 'overallOfficials': [{'name': 'Heather Blewett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Agriculture and Agri-Food Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Boniface Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agriculture and Agri-Food Canada', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Dr. Heather Blewett', 'investigatorAffiliation': 'St. Boniface Hospital'}}}}