Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-12 @ 5:16 AM
Study NCT ID:
NCT07242066
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dietary Nitrate and Vitamin C Co-supplementation on Blood Pressure and Endothelial Function in Overweight Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Pre, 24 hours, 48 hours and 72 hours after supplementation', 'description': 'Resting diastolic and systolic blood pressure using portable automated monitor'}, {'measure': 'Cardiac function', 'timeFrame': 'Pre and post 3 days of supplementation', 'description': 'Resting cardiac function using a non-invasive methodology (Finometer)'}], 'secondaryOutcomes': [{'measure': 'Flow-mediated dilation', 'timeFrame': 'Pre and post 3 days of supplementation', 'description': 'Assess endothelial function through changes in brachial artery diameter in response to reactive hyperaemia using high-resolution B-mode ultrasound.'}, {'measure': 'Saliva nitrate concentration', 'timeFrame': 'Pre and post 3 days supplementation', 'description': 'Colorimetric assays based on the Griess reaction will be used to measure nitrate concentration in saliva samples'}, {'measure': 'Urinary nitrate concentration', 'timeFrame': 'Pre and post 3 days supplementation', 'description': 'Colorimetric assays based on the Griess reaction will be used to measure nitrate concentration in urine samples'}, {'measure': 'Saliva nitrite concentration', 'timeFrame': 'Pre and post 3 days supplementation', 'description': 'Colorimetric assays based on the Griess reaction will be used to measure nitrite concentration in saliva samples'}, {'measure': 'Urine vitamin C concentration', 'timeFrame': 'Pre and post 3 days supplementation', 'description': 'A colorimetric assay kit will be used to measure vitamin C in urine samples'}, {'measure': 'Urine 8-isoprastane concentration', 'timeFrame': 'Pre and post 3 days supplementation', 'description': 'An Enzyme Linked Immuosorbant assay will be used to determine 8-isoprostane concentrations in urine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular disease', 'endothelial function', 'nitrate', 'Vitamin C'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '17353456', 'type': 'BACKGROUND', 'citation': 'Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. doi: 10.1161/CIRCULATIONAHA.106.652859. No abstract available.'}, {'pmid': '20306272', 'type': 'BACKGROUND', 'citation': 'Forstermann U. Nitric oxide and oxidative stress in vascular disease. Pflugers Arch. 2010 May;459(6):923-39. doi: 10.1007/s00424-010-0808-2. Epub 2010 Mar 21.'}, {'pmid': '21284528', 'type': 'BACKGROUND', 'citation': 'Gori T, Munzel T. Oxidative stress and endothelial dysfunction: therapeutic implications. Ann Med. 2011 Jun;43(4):259-72. doi: 10.3109/07853890.2010.543920. Epub 2011 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have shown in two short-term studies in healthy, young participants that the combined supplementation of inorganic nitrate with vitamin C has beneficial effects on blood pressure and blood vessel wall stiffness. However, the effects of the combined supplementation have not been tested in individuals at greater cardiovascular disease risk. The investigators would like to show whether inorganic nitrate and vitamin C will produce greater effects on blood pressure and endothelial function when compared to inorganic nitrate alone versus the placebo treatment in people at greater risk of cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Participant is willing and able to comply with the requirements of the study protocol.\n* Non-smoking men and women.\n* Aged between 50-75 years.\n* Overweight and obese (BMI: over 25.0 kg/m2).\n\nExclusion Criteria:\n\n* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.\n* Vegetarian.\n* Smoking.\n* Resting systolic blood pressure greater than 160 mmHg; diastolic blood pressure greater than 100 mmHg.\n* Active cancer and any diagnosis of malignant cancer in the last 5 years.\n* Excessive alcohol intake (\\>21 units per week).\n* Allergy or intolerance to the intervention food (Beetroot juice).\n* Diagnosis of chronic or acute metabolic and inflammatory conditions that may interfere with the study outcomes.\n* Major surgical operations.\n* Use of prescribed psychiatric drugs (antidepressants, sedatives, antipsychotics), diuretics, organic nitrates, statins and proton pump inhibitors.\n* Use of prescribed hormonal therapies (oestrogens, thyroxin, and progesterone), anti-hypertensive (Calcium++ channel blockers, beta-blockers, and angiotensin-converting-enzyme (ACE) inhibitors), only if the prescription had started, or the dose had been started/changed, in the previous three months.\n* Non-prescribed dietary supplements if not stopped at least for 2 weeks before starting the trial.\n* Use of the mouthwash during the study was not allowed as it interferes with the conversion of oral nitrate into nitrite.'}, 'identificationModule': {'nctId': 'NCT07242066', 'briefTitle': 'Effects of Dietary Nitrate and Vitamin C Co-supplementation on Blood Pressure and Endothelial Function in Overweight Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Effects of Dietary Nitrate and Vitamin C Co-supplementation on Blood Pressure and Endothelial Function in Overweight Individuals', 'orgStudyIdInfo': {'id': 'FHMS 128-0224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo beetroot juice and tablet', 'interventionNames': ['Dietary Supplement: Nitrate-depleted beetroot juice plus placebo tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Beetroot juice + Vitamin C', 'description': 'Beetroot juice and Vitamin C', 'interventionNames': ['Dietary Supplement: Beetroot juice plus vitamin C tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Beetroot juice + placebo', 'description': 'Beetroot juice + placebo tablet', 'interventionNames': ['Dietary Supplement: Beetroot juice plus placebo tablet']}], 'interventions': [{'name': 'Beetroot juice plus vitamin C tablet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Concentrated beetroot juice (70 ml in the morning before breakfast and 70 ml in the evening before dinner) plus Vitamin C tablets (500mg/tablet)', 'armGroupLabels': ['Beetroot juice + Vitamin C']}, {'name': 'Beetroot juice plus placebo tablet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Concentrated beetroot juice (70ml in the morning and 70 ml in the evening) plus placebo tablets (containing 500 mg of the non-nutritive sweetener aspartame)', 'armGroupLabels': ['Beetroot juice + placebo']}, {'name': 'Nitrate-depleted beetroot juice plus placebo tablet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'nitrate-depleted beetroot juice (70ml in the morning and 70 ml in the evening) plus placebo tablets (containing 500 mg of the non-nutritive sweetener aspartame)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'David Greenfield Human Physiology Lab, Queens Medical Centre', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Human Physiology', 'investigatorFullName': 'Kostas Tsintzas', 'investigatorAffiliation': 'University of Nottingham'}}}}