Blood PressurePhase 4NO-whatNCT02271633
Nitrate Supplementation; Source
A Phase 4 study testing Sodium nitrate, Beetroot juice and Spinach in people with Blood Pressure and Nutritional Physiological Phenomena, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The main aim of the current study will be to compare the effects of ingesting different nitrate-rich sources on plasma nitrite concentrations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Nutritional Physiological Phenomena
- What is being tested?
- Sodium nitrate, Beetroot juice and Spinach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18.5 < BMI < 30 kg/m2
- Engagement in regular physical activity ( > 1 h a week)
Who cannot join
- Use of medication
- Smoking
- Currently supplementing diet with nitrate
- Lactose intolerance
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6200MD
About this study
Official title: The Effect of Nitrate Supplementation: Source of Supplementation
The main aim of the current study will be to compare the effects of ingesting different nitrate-rich sources on plasma nitrite concentrations.
Read the detailed description
Oral ingestion of nitrate (NO3-) has been shown to increase plasma nitrate and nitrite levels. Significant lowering of pulmonary oxygen uptake during exercise, as well as significantly lower blood pressure values at rest have been observed after supplementation with nitrate. However, no study has yet described a direct comparison between different nitrate-rich beverages with respect to the bioavailability of nitrate/nitrite and the possible hemodynamic effects. Based on the gaps in current literature, our main goal will therefore be to gain further insight into the effects of nitrate supplementation with different sources on plasma nitrite levels.
- Being tested
- Sodium nitrate, Beetroot juice, Spinach, Rocket salad
- Keywords
- Nitrate, Bioavailability, Sports
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium nitrateDietary supplement
Beetroot juiceDietary supplement
SpinachDietary supplement
Rocket saladDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sodium nitrate | Active comparator | Dietary supplement: 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany) Receives: Dietary Supplement: Beetroot juice; Dietary Supplement: Spinach; Dietary Supplement: Rocket salad |
| Beetroot juice | Active comparator | Dietary supplement: 800 mg of nitrate in concentrated beetroot juice (Beet-IT) Receives: Dietary Supplement: Sodium nitrate; Dietary Supplement: Spinach; Dietary Supplement: Rocket salad |
| Spinach | Active comparator | Dietary supplement: 800 mg of nitrate in a spinach based beverage Receives: Dietary Supplement: Sodium nitrate; Dietary Supplement: Beetroot juice; Dietary Supplement: Rocket salad |
| Rocket salad | Active comparator | Dietary supplement: 800 mg of nitrate in a rocket salad based beverage Receives: Dietary Supplement: Sodium nitrate; Dietary Supplement: Beetroot juice; Dietary Supplement: Spinach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nitrite levels
Plasma nitrite levels following ingestion of dietary nitrate
Measured: Baseline until 5 hours after ingestion
Secondary outcomes (3)
Plasma levels of nitrate
Plasma nitrate levels following ingestion of dietary nitrate
Measured: Baseline until 5 hours post-ingestion
Resting blood pressure
Resting blood pressure measures following ingestion of dietary nitrate
Measured: Baseline, 2.5 hours and 5 hours post-ingestion
Tongue scraping to assess bacterial mouth flora.
Tongue scraping to assess bacterial mouth flora.
Measured: 5 h post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lex Verdijk, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271633
- Sponsor's protocol ID
- METC14-3-020
- Acronym
- NO-what
- Status last verified
- May 2015
- First submitted
- 13 Oct 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.
PubMed 23640589van Velzen AG, Sips AJ, Schothorst RC, Lambers AC, Meulenbelt J. The oral bioavailability of nitrate from nitrate-rich vegetables in humans. Toxicol Lett. 2008 Oct 1;181(3):177-81. doi: 10.1016/j.toxlet.2008.07.019. Epub 2008 Aug 3.
PubMed 18723086Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
PubMed 22414688Liu AH, Bondonno CP, Croft KD, Puddey IB, Woodman RJ, Rich L, Ward NC, Vita JA, Hodgson JM. Effects of a nitrate-rich meal on arterial stiffness and blood pressure in healthy volunteers. Nitric Oxide. 2013 Nov 30;35:123-30. doi: 10.1016/j.niox.2013.10.001. Epub 2013 Oct 10.
PubMed 24120618Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. doi: 10.1123/ijsnem.22.1.64.
PubMed 22248502Jonvik KL, Nyakayiru J, Pinckaers PJ, Senden JM, van Loon LJ, Verdijk LB. Nitrate-Rich Vegetables Increase Plasma Nitrate and Nitrite Concentrations and Lower Blood Pressure in Healthy Adults. J Nutr. 2016 May;146(5):986-93. doi: 10.3945/jn.116.229807. Epub 2016 Apr 13.
PubMed 27075914
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitrate Supplementation: Source of Supplementation
- ClinicalTrials.gov ID
- NCT02271633
- Acronym / sponsor ID
- NO-what / METC14-3-020
- Keywords
- Nitrate, Bioavailability, Sports
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the current study will be to compare the effects of ingesting different nitrate-rich sources on plasma nitrite concentrations.
Detailed description
Oral ingestion of nitrate (NO3-) has been shown to increase plasma nitrate and nitrite levels. Significant lowering of pulmonary oxygen uptake during exercise, as well as significantly lower blood pressure values at rest have been observed after supplementation with nitrate. However, no study has yet described a direct comparison between different nitrate-rich beverages with respect to the bioavailability of nitrate/nitrite and the possible hemodynamic effects. Based on the gaps in current literature, our main goal will therefore be to gain further insight into the effects of nitrate supplementation with different sources on plasma nitrite levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium nitrate | Active comparator | Dietary Supplement: Beetroot juice, Dietary Supplement: Spinach, Dietary Supplement: Rocket saladDietary supplement: 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany) |
| Beetroot juice | Active comparator | Dietary Supplement: Sodium nitrate, Dietary Supplement: Spinach, Dietary Supplement: Rocket saladDietary supplement: 800 mg of nitrate in concentrated beetroot juice (Beet-IT) |
| Spinach | Active comparator | Dietary Supplement: Sodium nitrate, Dietary Supplement: Beetroot juice, Dietary Supplement: Rocket saladDietary supplement: 800 mg of nitrate in a spinach based beverage |
| Rocket salad | Active comparator | Dietary Supplement: Sodium nitrate, Dietary Supplement: Beetroot juice, Dietary Supplement: SpinachDietary supplement: 800 mg of nitrate in a rocket salad based beverage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18.5 < BMI < 30 kg/m2
- Engagement in regular physical activity ( > 1 h a week)
Key exclusion criteria (4 listed)
- Use of medication
- Smoking
- Currently supplementing diet with nitrate
- Lactose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium nitrate | Dietary supplement | Beetroot juice, Rocket salad, Spinach |
| Beetroot juice | Dietary supplement | Rocket salad, Sodium nitrate, Spinach |
| Spinach | Dietary supplement | Beetroot juice, Rocket salad, Sodium nitrate |
| Rocket salad | Dietary supplement | Beetroot juice, Sodium nitrate, Spinach |
Primary outcome
Plasma nitrite levels
Time frame: Baseline until 5 hours after ingestion
Plasma nitrite levels following ingestion of dietary nitrate
3 secondary outcomes
Plasma levels of nitrate
Time frame: Baseline until 5 hours post-ingestion
Resting blood pressure
Time frame: Baseline, 2.5 hours and 5 hours post-ingestion
Tongue scraping to assess bacterial mouth flora.
Time frame: 5 h post-ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 23640589Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.
- Background: PubMed 18723086van Velzen AG, Sips AJ, Schothorst RC, Lambers AC, Meulenbelt J. The oral bioavailability of nitrate from nitrate-rich vegetables in humans. Toxicol Lett. 2008 Oct 1;181(3):177-81. doi: 10.1016/j.toxlet.2008.07.019. Epub 2008 Aug 3.
- Background: PubMed 22414688Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
- Background: PubMed 24120618Liu AH, Bondonno CP, Croft KD, Puddey IB, Woodman RJ, Rich L, Ward NC, Vita JA, Hodgson JM. Effects of a nitrate-rich meal on arterial stiffness and blood pressure in healthy volunteers. Nitric Oxide. 2013 Nov 30;35:123-30. doi: 10.1016/j.niox.2013.10.001. Epub 2013 Oct 10.
- Background: PubMed 22248502Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. doi: 10.1123/ijsnem.22.1.64.
- Derived from this study: PubMed 27075914Jonvik KL, Nyakayiru J, Pinckaers PJ, Senden JM, van Loon LJ, Verdijk LB. Nitrate-Rich Vegetables Increase Plasma Nitrate and Nitrite Concentrations and Lower Blood Pressure in Healthy Adults. J Nutr. 2016 May;146(5):986-93. doi: 10.3945/jn.116.229807. Epub 2016 Apr 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lex Verdijk, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium nitrate, Beetroot juice and Spinach in people with Blood Pressure and Nutritional Physiological Phenomena, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma nitrite levels (time frame: Baseline until 5 hours after ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271633, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.