Endothelial DysfunctionNCT04283630
Nitrate and Vitamin C on Vascular Health Oxidative Stress
A study testing Dietary nitrate in the form of beetroot juice for all participnats and Nature Made vitamin c 1000 mg in people with Endothelial Dysfunction, run by David Travis Thomas at 2 sites in United States.
Trial summary
The objective of this study is to examine whether the co-administration of dietary nitrate combined with vitamin C for 4 weeks in patients at risk for CVD would yield robust effects on endothelial function using blood measures and a non-invasive technique (Peripheral Artery Tonometry) compared to dietary nitrate… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Dietary nitrate in the form of beetroot juice for all participnats and Nature Made vitamin c 1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2018to 13 Dec 2019
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: between 50 and 70 years
- Body mass index (BMI) of 18.5-34.9 kg/m2
- Reactive hyperemia index (RHI) of < or equal to 2
- High cholesterol levels with LDL concentrations (>130 mg/dL)
- Not receiving any lipid lowering therapy.
- Non-smokers
Who cannot join
- Evidence of overt atherosclerotic disease (i.e., documented medical history of coronary artery disease, peripheral artery disease, cardiovascular disease, and stroke).
- Any surgery or medical history that could confound study results, such as a history of bowel resection, rheumatoid arthritis, inflammatory bowel disease, celiac disease, diabetes, uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg), controlled hypertension on clonidine medication.
- Participants were ineligible if they had been diagnosed with the following medical conditions such as active cancer, severe anemia (Hb < 10mg/dL), hepatic or renal disease, heart failure, or finger deformities.
- HIV-positive patients on combination antiretroviral therapy because of potential pharmacokinetic interactions with beetroot juice were excluded.
- Participants were also excluded if they reported taking any form of hormone replacement therapy (estrogens, progesterone, and testosterone), multivitamin supplements that provides >100% of RDA, or any of the following medications that attenuate nitrate conversion to NO: proton pump inhibitors (PPI) and antibiotics.
- Participants who consumed greater than 6 drinks of alcohol (any form) per week, performed structured resistance or aerobic training for more than 1-hour four times per week, or participated in other clinical intervention within the previous 30 days were excluded from the study.
- Eligible subjects were asked to avoid using the mouthwash before and throughout the study duration. In addition, enrolled participants were advised to consume low- vitamin c diet throughout the study. They were provided at the beginning of the study with a list of high vitamin C foods/fortified foods to avoid during the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40514
University of Kentucky
Lexington, Kentucky, 40536
About this study
Official title: The Combined Effect of Dietary Nitrate and Vitamin C on Endothelial Function, Oxidative Stress Biomarkers, and Blood Lipids
The objective of this study is to examine whether the co-administration of dietary nitrate combined with vitamin C for 4 weeks in patients at risk for CVD would yield robust effects on endothelial function using blood measures and a non-invasive technique (Peripheral Artery Tonometry) compared to dietary nitrate supplementation alone.
Read the detailed description
This is a 10 week randomized, cross-over, double-blinded, placebo-controlled study. This study was designed to compare the magnitude changes in RHI (primary outcome), plasma NO metabolites (nitrate and nitrite), and plasma vitamin C, plasma oxidized LDL, and blood (secondary outcome) following treatment with inorganic nitrate and vitamin C placebo (N) and inorganic nitrate combined with vitamin C (NC). Following baseline testing, eligible subjects were randomized to receive either treatment (N) or treatment (NC) for 4 weeks (period1), and participants were then crossed over to the alternate treatment for another 4 weeks (period 2). There was a 2-week washout at crossover.
- Conditions
- Endothelial Dysfunction
- Being tested
- Dietary nitrate in the form of beetroot juice for all participnats, Nature Made vitamin c 1000 mg, Placebo
- Keywords
- Nitrate, Vitamin C, Endothelial function, Nitric Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary nitrate in the form of beetroot juice for all participnatsDietary supplement
Also called Sport Beet IT shot
participants asked to consume dietary nitrate in the form of beet juice everyday in the morning and then one hour later, the vitamin C capsules.
Nature Made vitamin c 1000 mgDietary supplement
vitamin C and the placebo were provided as supplement capsules. Participants were asked to consume one dose/shot of sport Beet IT (70ml) that delivers on average 300-400mg of inorganic nitrate every day in the morning during the four-week study period, except for the test days and washout weeks. Accordingly, the participant were asked to consume the daily vitamin C supplement (1000 mg) or placebo one-hour post beetroot juice supplementation.
PlaceboDietary supplement
Vitamin C matched Placebo capsules that made from starch.
| Study group | Role | What they receive |
|---|---|---|
| Randomization and Dietary supplement Interventions | Active comparator | The dietary nitrate supplement was provided in the form of commercial beetroot juice (Sport Beet IT shot, Heartbeet Ltd) for all participants, whereas vitamin C and the placebo were provided as supplement capsules. Participants were asked to consume one dose/shot of sport Beet IT (70ml) that delivers on average 300-400mg of inorganic nitrate every day in the morning during the four-week study period, except for the test days and washout weeks. Accordingly, the participant were asked to consume the concentrated beetroot juice with breakfast meals, and then the vitamin C supplement (1000 mg)or placebo at the same time one-hour post beetroot juice supplementation Receives: Dietary Supplement: Dietary nitrate in the form of beetroot juice for all participnats; Dietary Supplement: Nature Made vitamin c 1000 mg |
| Placebo | Placebo comparator | Vitamin C placebo was matched with the active vitamin c capsules in shape, color, and size. Receives: Dietary Supplement: Dietary nitrate in the form of beetroot juice for all participnats; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of peripheral endothelial function
Non-invasive technique called peripheral artery tonometry reactive hyperemia (PAT-RH)
Measured: Change from baseline endothelial function at 4 weeks of each treatment intervention period
Secondary outcomes (3)
Change of plasma total nitric oxide (NOx)
Sum of nitric oxide metabolites (nitrite and nitrate) were assessed
Measured: Change from baseline plasma NOx at 4 weeks of each treatment intervention period
Change of blood biomarker of oxidative stress
Oxidized low density lipoprotein (oxLDL)
Measured: Change from baseline oxLDL at 4 weeks of each treatment intervention period
Change of blood lipids
Total cholesterol(TC), low density lipoprotein(LDL), triglycerides(TG), and high density lipoprotein (HDL)
Measured: Change from baseline blood lipids at 4 weeks of each treatment intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start5 Feb 2018
- Primary completion15 Sep 2019
- Study completion13 Dec 2019
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 Endothelial DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover double blinded crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Travis Thomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Travis Thomas, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283630
- Sponsor's protocol ID
- 17-0412-F3R
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basaqr R, Skleres M, Jayswal R, Thomas DT. The effect of dietary nitrate and vitamin C on endothelial function, oxidative stress and blood lipids in untreated hypercholesterolemic subjects: A randomized double-blind crossover study. Clin Nutr. 2021 Apr;40(4):1851-1860. doi: 10.1016/j.clnu.2020.10.012. Epub 2020 Oct 14.
PubMed 33115598
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Dietary Nitrate and Vitamin C on Endothelial Function, Oxidative Stress Biomarkers, and Blood Lipids
- ClinicalTrials.gov ID
- NCT04283630
- Acronym / sponsor ID
- 17-0412-F3R
- Conditions
- Endothelial Dysfunction
- Keywords
- Nitrate, Vitamin C, Endothelial function, Nitric Oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- David Travis ThomasUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 25 Feb 2020 (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 objective of this study is to examine whether the co-administration of dietary nitrate combined with vitamin C for 4 weeks in patients at risk for CVD would yield robust effects on endothelial function using blood measures and a non-invasive technique (Peripheral Artery Tonometry) compared to dietary nitrate supplementation alone.
Detailed description
This is a 10 week randomized, cross-over, double-blinded, placebo-controlled study. This study was designed to compare the magnitude changes in RHI (primary outcome), plasma NO metabolites (nitrate and nitrite), and plasma vitamin C, plasma oxidized LDL, and blood (secondary outcome) following treatment with inorganic nitrate and vitamin C placebo (N) and inorganic nitrate combined with vitamin C (NC). Following baseline testing, eligible subjects were randomized to receive either treatment (N) or treatment (NC) for 4 weeks (period1), and participants were then crossed over to the alternate treatment for another 4 weeks (period 2). There was a 2-week washout at crossover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover double blinded crossover study
| Arm | Type | Receives |
|---|---|---|
| Randomization and Dietary supplement Interventions | Active comparator | Dietary Supplement: Dietary nitrate in the form of beetroot juice for all participnats, Dietary Supplement: Nature Made vitamin c 1000 mgThe dietary nitrate supplement was provided in the form of commercial beetroot juice (Sport Beet IT shot, Heartbeet Ltd) for all participants, whereas vitamin C and the placebo were provided as supplement capsules. Participants were asked to consume one dose/shot of sport Beet IT (70ml) that delivers on average 300-400mg of inorganic nitrate every day in the morning during the four-week study period, except for the test days and washout weeks. Accordingly, the participant were asked to consume the concentrated beetroot juice with breakfast meals, and then the vitamin C supplement (1000 mg)or placebo at the same time one-hour post beetroot juice supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Dietary nitrate in the form of beetroot juice for all participnats, Dietary Supplement: PlaceboVitamin C placebo was matched with the active vitamin c capsules in shape, color, and size. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: between 50 and 70 years
- Body mass index (BMI) of 18.5-34.9 kg/m2
- Reactive hyperemia index (RHI) of < or equal to 2
- High cholesterol levels with LDL concentrations (>130 mg/dL)
- Not receiving any lipid lowering therapy.
Key exclusion criteria (7 listed)
- Evidence of overt atherosclerotic disease (i.e., documented medical history of coronary artery disease, peripheral artery disease, cardiovascular disease, and stroke).
- Any surgery or medical history that could confound study results, such as a history of bowel resection, rheumatoid arthritis, inflammatory bowel disease, celiac disease, diabetes, uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg), controlled hypertension on clonidine medication.
- Participants were ineligible if they had been diagnosed with the following medical conditions such as active cancer, severe anemia (Hb < 10mg/dL), hepatic or renal disease, heart failure, or finger deformities.
- HIV-positive patients on combination antiretroviral therapy because of potential pharmacokinetic interactions with beetroot juice were excluded.
- Participants were also excluded if they reported taking any form of hormone replacement therapy (estrogens, progesterone, and testosterone), multivitamin supplements that provides >100% of RDA, or any of the following medications that attenuate nitrate conversion to NO: proton pump inhibitors (PPI) and antibiotics.
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 |
|---|---|---|
| Dietary nitrate in the form of beetroot juice for all participnatsAlso: Sport Beet IT shotparticipants asked to consume dietary nitrate in the form of beet juice everyday in the morning and then one hour later, the vitamin C capsules. | Dietary supplement | Placebo, Randomization and Dietary supplement Interventions |
| Nature Made vitamin c 1000 mgvitamin C and the placebo were provided as supplement capsules. Participants were asked to consume one dose/shot of sport Beet IT (70ml) that delivers on average 300-400mg of inorganic nitrate every day in the morning during the four-week study period, except for the test days and washout weeks. Accordingly, the participant were asked to consume the daily vitamin C supplement (1000 mg) or placebo one-hour post beetroot juice supplementation. | Dietary supplement | Randomization and Dietary supplement Interventions |
| PlaceboVitamin C matched Placebo capsules that made from starch. | Dietary supplement | Placebo |
Primary outcome
Change of peripheral endothelial function
Time frame: Change from baseline endothelial function at 4 weeks of each treatment intervention period
Non-invasive technique called peripheral artery tonometry reactive hyperemia (PAT-RH)
3 secondary outcomes
Change of plasma total nitric oxide (NOx)
Time frame: Change from baseline plasma NOx at 4 weeks of each treatment intervention period
Change of blood biomarker of oxidative stress
Time frame: Change from baseline oxLDL at 4 weeks of each treatment intervention period
Change of blood lipids
Time frame: Change from baseline blood lipids at 4 weeks of each treatment intervention period
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 25 Feb 2020.
- Derived from this study: PubMed 33115598Basaqr R, Skleres M, Jayswal R, Thomas DT. The effect of dietary nitrate and vitamin C on endothelial function, oxidative stress and blood lipids in untreated hypercholesterolemic subjects: A randomized double-blind crossover study. Clin Nutr. 2021 Apr;40(4):1851-1860. doi: 10.1016/j.clnu.2020.10.012. Epub 2020 Oct 14.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary nitrate in the form of beetroot juice for all participnats and Nature Made vitamin c 1000 mg in people with Endothelial Dysfunction, run by David Travis Thomas at 2 sites 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 6 inclusion and 7 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change of peripheral endothelial function (time frame: Change from baseline endothelial function at 4 weeks of each treatment intervention period). 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 NCT04283630, 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 25 Feb 2020.