Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-02-01 @ 4:52 PM
Study NCT ID:
NCT02715635
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2016-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014436', 'term': 'Typhoid-Paratyphoid Vaccines'}, {'id': 'C057664', 'term': 'Vi polysaccharide vaccine, typhoid'}], 'ancestors': [{'id': 'D022562', 'term': 'Salmonella Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2016-03-16', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow mediated dilatation', 'timeFrame': 'Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)', 'description': 'Comparison of change in FMD from baseline after typhoid vaccination following inorganic nitrate versus placebo supplementation'}, {'measure': 'Plasma nitrite concentration', 'timeFrame': 'Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)', 'description': 'Comparison of change in plasma nitrite concentration following inorganic nitrate versus placebo supplementation'}], 'secondaryOutcomes': [{'measure': 'Markers of acute inflammation', 'timeFrame': 'Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)', 'description': 'Comparison of change in peripheral markers of inflammation and leucocyte count following nitrate versus placebo supplementation'}, {'measure': 'Pulse wave velocity', 'timeFrame': 'Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)', 'description': 'Comparison of change in PWV from baseline after typhoid vaccination following nitrate versus placebo supplementation'}, {'measure': 'Platelet reactivity', 'timeFrame': 'Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)', 'description': 'Comparison of change in platelet reactivity from baseline after typhoid vaccination following nitrate versus placebo supplementation'}, {'measure': 'Plasma nitrate concentration', 'timeFrame': 'Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)', 'description': 'Comparison of change in plasma nitrate concentration following inorganic nitrate versus placebo supplementation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '10961963', 'type': 'BACKGROUND', 'citation': 'Hingorani AD, Cross J, Kharbanda RK, Mullen MJ, Bhagat K, Taylor M, Donald AE, Palacios M, Griffin GE, Deanfield JE, MacAllister RJ, Vallance P. Acute systemic inflammation impairs endothelium-dependent dilatation in humans. Circulation. 2000 Aug 29;102(9):994-9. doi: 10.1161/01.cir.102.9.994.'}, {'pmid': '12045164', 'type': 'BACKGROUND', 'citation': 'Kharbanda RK, Walton B, Allen M, Klein N, Hingorani AD, MacAllister RJ, Vallance P. Prevention of inflammation-induced endothelial dysfunction: a novel vasculo-protective action of aspirin. Circulation. 2002 Jun 4;105(22):2600-4. doi: 10.1161/01.cir.0000017863.52347.6c.'}, {'pmid': '17084260', 'type': 'BACKGROUND', 'citation': 'Donald AE, Charakida M, Cole TJ, Friberg P, Chowienczyk PJ, Millasseau SC, Deanfield JE, Halcox JP. Non-invasive assessment of endothelial function: which technique? J Am Coll Cardiol. 2006 Nov 7;48(9):1846-50. doi: 10.1016/j.jacc.2006.07.039. Epub 2006 Oct 17.'}, {'pmid': '15364625', 'type': 'BACKGROUND', 'citation': 'Clapp BR, Hingorani AD, Kharbanda RK, Mohamed-Ali V, Stephens JW, Vallance P, MacAllister RJ. Inflammation-induced endothelial dysfunction involves reduced nitric oxide bioavailability and increased oxidant stress. Cardiovasc Res. 2004 Oct 1;64(1):172-8. doi: 10.1016/j.cardiores.2004.06.020.'}, {'pmid': '40209616', 'type': 'DERIVED', 'citation': 'Lau C, Primus CP, Shabbir A, Chhetri I, Ono M, Masucci M, Bin Noorany Aubdool MA, Amarin J, Hamers AJ, Khan Z, Kumar NA, Montalvo Moreira SA, Nuredini G, Osman M, Whitear C, Godec T, Kapil V, Massimo G, Khambata RS, Rathod KS, Ahluwalia A. Accelerating inflammatory resolution in humans to improve endothelial function and vascular health: Targeting the non-canonical pathway for NO. Redox Biol. 2025 May;82:103592. doi: 10.1016/j.redox.2025.103592. Epub 2025 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The principal research objective is to determine whether inorganic nitrate in the form of beetroot juice compared to placebo control prevents the systemic inflammation that underlies typhoid vaccine-induced endothelial dysfunction', 'detailedDescription': 'We wish to determine in a prospective manner whether inorganic nitrate affects the endothelial dysfunction induced by systemic inflammation. At baseline we will measure flow-mediated dilatation (FMD) and peripheral augmentation index, as well as aortic stiffness, as measured by pulse wave velocity (PWV). Volunteers will then receive \\~8 mmols of dietary nitrate or nitrate free placebo juice once daily for 6 days. After this, depending on availability, volunteers will receive a typhoid vaccine Typherix®, GlaxoSmithKline UK or Typhim Vi ™, AAH Pharmaceuticals Ltd). This vaccine generates a mild systemic inflammation that is associated with vascular dysfunction. All vascular function measures will be repeated at 8 hours and 32 hours after vaccine administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy volunteers\n2. Aged 18-45\n3. Volunteers who are willing to sign the consent form.\n4. Normal resting blood pressure (\\<140/90 mmHg)\n\nExclusion Criteria:\n\n1. Healthy subjects unwilling to consent\n2. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result\n3. History of any serious illnesses, including recent infections or trauma\n4. Subjects taking systemic medication (other than the oral contraceptive pill)\n5. Subjects with self-reported use of mouthwash or tongue scrapes\n6. Subjects with recent (3 months) or current antibiotic use\n7. Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis\n8. Subjects with a history of typhoid vaccination in the last 6 months\n9. Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV'}, 'identificationModule': {'nctId': 'NCT02715635', 'briefTitle': 'Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate on a Model of Vascular Dysfunction in Healthy Volunteers', 'orgStudyIdInfo': {'id': '15/LO/0789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrate-rich beetroot juice', 'description': 'Biological: Typhoid vaccine The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution Other Name: Typhim Vi®\n\nDietary Supplement: Concentrate beetroot Juice 140 ml containing \\~8 mmol of inorganic nitrate', 'interventionNames': ['Biological: Typhoid vaccine', 'Dietary Supplement: Concentrate beetroot Juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nitrate-deplete beetroot juice', 'description': 'Biological: Typhoid vaccine The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution Other Name: Typhim Vi®\n\nDietary Supplement: Concentrate beetroot Juice 140 ml which is nitrate-depleted', 'interventionNames': ['Biological: Typhoid vaccine', 'Dietary Supplement: Concentrate beetroot Juice (Placebo)']}], 'interventions': [{'name': 'Typhoid vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Typhim Vi®'], 'description': 'The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution', 'armGroupLabels': ['Nitrate-deplete beetroot juice', 'Nitrate-rich beetroot juice']}, {'name': 'Concentrate beetroot Juice', 'type': 'DIETARY_SUPPLEMENT', 'description': '140 ml containing \\~8 mmol of inorganic nitrate', 'armGroupLabels': ['Nitrate-rich beetroot juice']}, {'name': 'Concentrate beetroot Juice (Placebo)', 'type': 'DIETARY_SUPPLEMENT', 'description': '140 ml which is nitrate-depleted', 'armGroupLabels': ['Nitrate-deplete beetroot juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1M 6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'William Harvey Research Institute, Barts and The London School of Medicine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Amrita Ahluwalia, BSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "William Harvey Research Institute, Barts and The London, Queen Mary's School of Medicine and Dentistry"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of The William Harvey Research Institute, Prof of Vascular Pharmacology', 'investigatorFullName': 'Amrita Ahluwalia', 'investigatorAffiliation': 'Queen Mary University of London'}}}}