Kidney Disease, ChronicNCT04103736
The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease
A study testing Beet It Sport Shot in people with Kidney Disease, Chronic and Endothelial Dysfunction, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of acute ingestion of a concentrated beetroot juice supplement on vascular function and exercise capacity in patients with moderate to severe chronic kidney disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Chronic, Endothelial Dysfunction
- What is being tested?
- Beet It Sport Shot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 29 Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 3-5 Chronic Kidney Disease
Who cannot join
- History of cardiovascular disease
- Current pregnancy
- Uncontrolled hypertension
- Uncontrolled hyperlipidemia
- Current hormone replacement therapy
- Current use of tobacco products
Show all 9Show fewer
- Current autoimmune disease
- Current hyperkalemia
- Diagnosis of a deep vein thrombosis (DVT) within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713
About this study
The purpose of this study is to examine the effect of acute ingestion of a concentrated beetroot juice supplement on vascular function and exercise capacity in patients with moderate to severe chronic kidney disease
Read the detailed description
People with Chronic Kidney Disease (CKD) are at an increased risk of cardiovascular disease. Blood vessel dysfunction and exercise intolerance are common in CKD. Blood vessel dysfunction has been shown to predict future cardiovascular events and decreased physical activity can contribute to an increased risk of cardiovascular disease. Therefore, this study investigates if dietary nitrate from beetroot juice, which has been shown to improve blood vessel function and exercise capacity in other cardiovascular disease pathologies, could be effective at improving these measures in patients with CKD. In a controlled, double blinded trial, stage 3-5 CKD patients will be randomly assigned to receive either beetroot beverage or a placebo and then complete measures of blood vessel function and an exercise test.
- Conditions
- Kidney Disease, Chronic, Endothelial Dysfunction
- Being tested
- Beet It Sport Shot, Nitrate-depleted placebo
- Keywords
- chronic kidney disease, dietary nitrates, beetroot juice, endothelium, vascular, cardiovascular disease, exercise capacity
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet It Sport ShotDietary supplement
Source of naturally occurring dietary nitrates
Nitrate-depleted placeboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Beet Juice Supplement | Experimental | A single, acute dose of Beet It Sport Shot containing ~12.6mmol naturally occurring dietary nitrates. Receives: Dietary Supplement: Beet It Sport Shot |
| Placebo juice | Placebo comparator | A single, acute dose of nitrate-depleted Beet It Sport Shot Receives: Dietary Supplement: Nitrate-depleted placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis
Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis
Measured: 2.5 hours post ingestion of juice
Secondary outcomes (5)
Endothelial function
Conduit artery endothelial function assessed by brachial artery flow mediated dilation
Measured: 2.5 hours post ingestion of juice
Blood pressure
Blood pressure recorded by automatic blood pressure machine
Measured: Change from pre-ingestion baseline to 2.5 hours post ingestion of juice
Arterial stiffness
Carotid to femoral pulse wave velocity assessed by tonometry
Measured: 2.5 hours post ingestion of juice
Pulse wave analysis
Central blood pressure and augmentation index assessed by oscillometry and radial tonometry
Measured: 2.5 hours post ingestion of juice
Peak aerobic capacity
Peak oxygen uptake (VO2 peak) during incremental cycling exercise to exhaustion
Measured: 2.5 hours post ingestion of juice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Dec 2015
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103736
- Sponsor's protocol ID
- 706281-6
- Status last verified
- Sep 2019
- First submitted
- 29 Apr 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04103736
- Acronym / sponsor ID
- 706281-6
- Conditions
- Kidney Disease, Chronic, Endothelial Dysfunction
- Keywords
- chronic kidney disease, dietary nitrates, beetroot juice, endothelium, vascular, cardiovascular disease, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 25 Sep 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 purpose of this study is to examine the effect of acute ingestion of a concentrated beetroot juice supplement on vascular function and exercise capacity in patients with moderate to severe chronic kidney disease
Detailed description
People with Chronic Kidney Disease (CKD) are at an increased risk of cardiovascular disease. Blood vessel dysfunction and exercise intolerance are common in CKD. Blood vessel dysfunction has been shown to predict future cardiovascular events and decreased physical activity can contribute to an increased risk of cardiovascular disease. Therefore, this study investigates if dietary nitrate from beetroot juice, which has been shown to improve blood vessel function and exercise capacity in other cardiovascular disease pathologies, could be effective at improving these measures in patients with CKD. In a controlled, double blinded trial, stage 3-5 CKD patients will be randomly assigned to receive either beetroot beverage or a placebo and then complete measures of blood vessel function and an exercise test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beet Juice Supplement | Experimental | Dietary Supplement: Beet It Sport ShotA single, acute dose of Beet It Sport Shot containing ~12.6mmol naturally occurring dietary nitrates. |
| Placebo juice | Placebo comparator | Dietary Supplement: Nitrate-depleted placeboA single, acute dose of nitrate-depleted Beet It Sport Shot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage 3-5 Chronic Kidney Disease
Key exclusion criteria (9 listed)
- History of cardiovascular disease
- Current pregnancy
- Uncontrolled hypertension
- Uncontrolled hyperlipidemia
- Current hormone replacement therapy
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 |
|---|---|---|
| Beet It Sport ShotSource of naturally occurring dietary nitrates | Dietary supplement | Beet Juice Supplement |
| Nitrate-depleted placeboPlacebo | Dietary supplement | Placebo juice |
Primary outcome
Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis
Time frame: 2.5 hours post ingestion of juice
Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis
5 secondary outcomes
Endothelial function
Time frame: 2.5 hours post ingestion of juice
Blood pressure
Time frame: Change from pre-ingestion baseline to 2.5 hours post ingestion of juice
Arterial stiffness
Time frame: 2.5 hours post ingestion of juice
Pulse wave analysis
Time frame: 2.5 hours post ingestion of juice
Peak aerobic capacity
Time frame: 2.5 hours post ingestion of juice
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 Sep 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet It Sport Shot in people with Kidney Disease, Chronic and Endothelial Dysfunction, run by University of Delaware 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 1 inclusion and 9 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 Sep 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?
Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis (time frame: 2.5 hours post ingestion of juice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2019.