Blood PressureNCT03909789
Effect of Inorganic Nitrate Supplement on Blood Pressure
A study testing Plant based bioequivalent Nitrate supplementation in people with Blood Pressure and Endothelial Dysfunction, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Endothelial Dysfunction
- What is being tested?
- Plant based bioequivalent Nitrate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 22 Jun 2018
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 40-75 years
- Hypertension >130/85 mmHg; men and women, 1:1 and stable medicated hypertensives
- Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
Who cannot join
- Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Weight in excess of 250 pounds
- Bleeding disorder
- History of known coronary artery disease, myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
- NYHA Class II- IV heart failure
- History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
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- Serum creatinine > 1.4 mg/dl
- Triglycerides > 400 at visit 1
- Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
- Concurrent enrollment in another placebo-controlled trial
- Partial ileal bypass or known gastrointestinal disease limiting drug absorption
- Current tobacco use
- Current use of anticoagulants (except for anti-platelet agents)
- Renal failure
- History of hypertensive encephalopathy or cerebrovascular accident
- Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Acute and Sustained Effects of Plant- Based Bio-Equivalent Nitrate Supplement Tablets on Blood Pressure Reduction, Nitric Oxide Mediated Endothelial Function and Saliva Bioconversion of Dietary Nitrate in Hypertensive Men and Women
The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.
Read the detailed description
This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide supplement for improving blood pressure and endothelial reactivity over a 12 weeks intervention period in individuals with metabolic syndrome. The study also examines the effect of plant-based bioequivalent Nitric Oxide supplement on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
- Conditions
- Blood Pressure, Endothelial Dysfunction
- Being tested
- Plant based bioequivalent Nitrate supplementation, Placebo
- Keywords
- Endothelium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant based bioequivalent Nitrate supplementationDietary supplement
The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| plant based bioequivalent dietary nitrate supplement | Active comparator | The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg. Receives: Dietary Supplement: Plant based bioequivalent Nitrate supplementation |
| placebo | Placebo comparator | The Placebo does not contain any nitric oxide supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in blood pressure
change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo
Measured: 12 weeks
Secondary outcomes (2)
changes in serum, plasma and salivary Nitrite and Nitrate
change in serum nitrate and nitrate levels (in mcg) over 12 weeks comparing active treatment to placebo
Measured: 12 weeks
cardiometabolic relevant biomarkers (as compared to placebo)
measures of serum markers of inflammation (Crp) and glucose over 12 weeks in active vs placebo arms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start17 Nov 2017
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909789
- Sponsor's protocol ID
- 21835-01
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cherukuri L, Birudaraju D, Kinninger A, Chaganti BT, Shekar C, Hamal S, Shaikh K, Flores F, Roy SK, Sotka W, Green SJ, Budoff MJ. Effect of a plant-based bioequivalent inorganic nitrate (NO3-) complex with vitamins, antioxidants and phytophenol rich food extracts in hypertensive individuals - A randomized, double-blind, placebo-controlled study. Clin Nutr ESPEN. 2020 Dec;40:327-335. doi: 10.1016/j.clnesp.2020.08.007. Epub 2020 Sep 7.
PubMed 33183558
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Sustained Effects of Plant- Based Bio-Equivalent Nitrate Supplement Tablets on Blood Pressure Reduction, Nitric Oxide Mediated Endothelial Function and Saliva Bioconversion of Dietary Nitrate in Hypertensive Men and Women
- ClinicalTrials.gov ID
- NCT03909789
- Acronym / sponsor ID
- 21835-01
- Conditions
- Blood Pressure, Endothelial Dysfunction
- Keywords
- Endothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 10 Apr 2019 (actual)
- 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 primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.
Detailed description
This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide supplement for improving blood pressure and endothelial reactivity over a 12 weeks intervention period in individuals with metabolic syndrome. The study also examines the effect of plant-based bioequivalent Nitric Oxide supplement on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| plant based bioequivalent dietary nitrate supplement | Active comparator | Dietary Supplement: Plant based bioequivalent Nitrate supplementationThe nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg. |
| placebo | Placebo comparator | Dietary Supplement: PlaceboThe Placebo does not contain any nitric oxide supplement. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 40-75 years
- Hypertension >130/85 mmHg; men and women, 1:1 and stable medicated hypertensives
- Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
Key exclusion criteria (17 listed)
- Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Weight in excess of 250 pounds
- Bleeding disorder
- History of known coronary artery disease, myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
- NYHA Class II- IV heart failure
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 |
|---|---|---|
| Plant based bioequivalent Nitrate supplementationThe nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg. | Dietary supplement | plant based bioequivalent dietary nitrate supplement |
| PlaceboPlacebo | Dietary supplement | placebo |
Primary outcome
Rate of change in blood pressure
Time frame: 12 weeks
change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo
2 secondary outcomes
changes in serum, plasma and salivary Nitrite and Nitrate
Time frame: 12 weeks
cardiometabolic relevant biomarkers (as compared to placebo)
Time frame: 12 weeks
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 12 Apr 2019.
- Derived from this study: PubMed 33183558Cherukuri L, Birudaraju D, Kinninger A, Chaganti BT, Shekar C, Hamal S, Shaikh K, Flores F, Roy SK, Sotka W, Green SJ, Budoff MJ. Effect of a plant-based bioequivalent inorganic nitrate (NO3-) complex with vitamins, antioxidants and phytophenol rich food extracts in hypertensive individuals - A randomized, double-blind, placebo-controlled study. Clin Nutr ESPEN. 2020 Dec;40:327-335. doi: 10.1016/j.clnesp.2020.08.007. Epub 2020 Sep 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant based bioequivalent Nitrate supplementation in people with Blood Pressure and Endothelial Dysfunction, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
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 3 inclusion and 17 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 12 Apr 2019. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Rate of change in blood pressure (time frame: 12 weeks). 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 NCT03909789, which also lists 1 linked publication.
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 12 Apr 2019.