Cardiovascular Diseases Clinical Trial
Official title:
A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Influence of Dietary Nitrate on Skin Inflammation in Healthy Volunteers
Verified date | June 2018 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the potential anti-inflammatory effects of inorganic dietary nitrate in a model of acute inflammation relevant to cardiovascular disease (CVD). Green leafy vegetables contain large amounts of inorganic nitrate, and research suggests that this nitrate has beneficial effects on the heart and blood vessels. The Ahluwalia Group have shown anti-inflammatory benefits of inorganic nitrate in pre-clinical models of CVD, early mechanistic studies in healthy volunteers, and in patients with hypertension, hypercholesterolaemia and those suffering acute heart attacks that translate to cardiovascular benefits. Understanding the mechanism of how this is achieved may open new therapeutic options in CVD. The Investigators therefore wish to explore whether inorganic nitrate might alter inflammatory responses using a blister-model of acute skin inflammation. This study is a randomised control trial with parallel limbs where half of patients receive nitrate-rich beetroot juice, and the other half a nitrate-deplete placebo beetroot juice.
Status | Completed |
Enrollment | 24 |
Est. completion date | November 1, 2020 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Healthy volunteers - Caucasian - Willing to provide informed consent Exclusion Criteria: - Healthy subjects unwilling to consent - Non-caucasian volunteers - History of any serious illnesses, including recent infections or trauma - Subjects taking systemic medication (other than the oral contraceptive pill) - Subjects with self-reported use of mouthwash or tongue scrapers - Subjects with recent or current antibiotic use - Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis - Subjects with a history of skin conditions - Subjects with and history of allergic reaction to any topical application - Subjects with any history of a bloodborne infectious disease such Hepatitis B or C virus, or HIV We have excluded non-caucasian volunteers due to a small incidence of prolonged skin hyperpigmentation in non-caucasians in previous studies. We have excluded subjects using mouthwash/tongue scrapers and oral conditions as we know that the nitrate ingested from the diet (i.e. beetroot juice) is converted to nitrite by the commensal bacteria in the back of the mouth. Subjects who have oral conditions or use mouthwash/tongue scrapers would have differences in oral bacterial populations, both in number and species. Therefore, by excluding these subjects, we will try and keep this variable as similar as possible in both groups. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Mary University of London | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
Day RM, Harbord M, Forbes A, Segal AW. Cantharidin blisters: a technique for investigating leukocyte trafficking and cytokine production at sites of inflammation in humans. J Immunol Methods. 2001 Nov 1;257(1-2):213-20. — View Citation
Jones DA, Pellaton C, Velmurugan S, Rathod KS, Andiapen M, Antoniou S, van Eijl S, Webb AJ, Westwood MA, Parmar MK, Mathur A, Ahluwalia A. Randomized phase 2 trial of intracoronary nitrite during acute myocardial infarction. Circ Res. 2015 Jan 30;116(3):437-47. doi: 10.1161/CIRCRESAHA.116.305082. Epub 2014 Dec 15. Erratum in: Circ Res. 2015 Mar 27;116(7):e55. — View Citation
Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24. — View Citation
Khambata RS, Ghosh SM, Rathod KS, Thevathasan T, Filomena F, Xiao Q, Ahluwalia A. Antiinflammatory actions of inorganic nitrate stabilize the atherosclerotic plaque. Proc Natl Acad Sci U S A. 2017 Jan 24;114(4):E550-E559. doi: 10.1073/pnas.1613063114. Epub 2017 Jan 5. — View Citation
Rathod KS, Kapil V, Velmurugan S, Khambata RS, Siddique U, Khan S, Van Eijl S, Gee LC, Bansal J, Pitrola K, Shaw C, D'Acquisto F, Colas RA, Marelli-Berg F, Dalli J, Ahluwalia A. Accelerated resolution of inflammation underlies sex differences in inflammatory responses in humans. J Clin Invest. 2017 Jan 3;127(1):169-182. doi: 10.1172/JCI89429. Epub 2016 Nov 28. — View Citation
Velmurugan S, Gan JM, Rathod KS, Khambata RS, Ghosh SM, Hartley A, Van Eijl S, Sagi-Kiss V, Chowdhury TA, Curtis M, Kuhnle GG, Wade WG, Ahluwalia A. Dietary nitrate improves vascular function in patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2016 Jan;103(1):25-38. doi: 10.3945/ajcn.115.116244. Epub 2015 Nov 25. Erratum in: Am J Clin Nutr. 2018 Apr 1;107(4):676. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in plasma nitrate levels | Comparison of change in plasma nitrite following dietary nitrate or placebo supplementation | 2 weeks | |
Primary | Change in blister fluid leucocytes | Comparison of change in blister fluid total and differential leucocyte numbers following dietary nitrate or placebo supplementation | 2 weeks | |
Secondary | Change in blister fluid cytokine composition | Comparison of change in blister fluid cytokine analysis following dietary nitrate or placebo supplementation | 2 weeks | |
Secondary | Change in peripheral markers of inflammation | Comparison of change in peripheral markers of inflammation and leucocyte count following dietary nitrate or placebo supplementation | 2 weeks | |
Secondary | Change in non-invasive blood pressure measurement | Comparison of change in blood pressure following dietary nitrate or placebo supplementation | 2 weeks |
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