A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate on a Model of Vascular Dysfunction in Healthy Volunteers
| Registry | NCT02715635 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 78 (Actual) |
| Sponsor | Queen Mary University of London (Other) |
| Conditions | Cardiovascular Diseases |
| Interventions | Typhoid vaccine, Concentrate beetroot Juice, Concentrate beetroot Juice (Placebo) (Biological, dietary supplement) |
| Dates | start 2016-04-01, primary completion 2020-12-01, completion 2021-08-01, first posted 2016-03-22, last updated 2022-07-20 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Cardiovascular Diseases All trials of Typhoid vaccine All trials of Concentrate beetroot Juice
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Nitrate-rich beetroot juice | Active comparator | Biological: Typhoid vaccine; Dietary Supplement: Concentrate beetroot Juice | 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® Dietary Supplement: Concentrate beetroot Juice 140 ml containing \~8 mmol of inorganic nitrate |
| Nitrate-deplete beetroot juice | Placebo comparator | Biological: Typhoid vaccine; Dietary Supplement: Concentrate beetroot Juice (Placebo) | 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® Dietary Supplement: Concentrate beetroot Juice 140 ml which is nitrate-depleted |
Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: 1. Healthy volunteers 2. Aged 18-45 3. Volunteers who are willing to sign the consent form. 4. Normal resting blood pressure (<140/90 mmHg) Exclusion Criteria: 1. Healthy subjects unwilling to consent 2. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result 3. History of any serious illnesses, including recent infections or trauma 4. Subjects taking systemic medication (other than the oral contraceptive pill) 5. Subjects with self-reported use of mouthwash or tongue scrapes 6. Subjects with recent (3 months) or current antibiotic use 7. Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis 8. Subjects with a history of typhoid vaccination in the last 6 months 9. Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV
| Facility | City | Country | Status |
|---|---|---|---|
| William Harvey Research Institute, Barts and The London School of Medicine | London | United Kingdom |