HypertensionDINO-CKDNCT07290842
The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
A study testing Beetroot Juice - Active in people with Hypertension and CKD - Chronic Kidney Disease, run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
The study aims to study the effects of diatery nitrate in patients with hypertension and hypertensive kidney injury. The study is a randomized, placebo-controlled, double-blinded crossover trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, CKD - Chronic Kidney Disease
- What is being tested?
- Beetroot Juice - Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Dec 2025to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension, treated with a maximum of 2 antihypertensive drugs and unattended office BP < 150/95 mmHg at the screening visit, or newly diagnosed without antihypertensive treatment by 24-hour BP or home BP measurement (above 130/80 or 135/85 respectively), and unattended office BP < 160/100 mmHg.
- CKD I-III based on hypertensive kidney injury. Patients, who previously met the criteria for CKD I within the last 5 years, but no longer has proteinuria after relevant treatment, can also be included. Diagnosis of CKD I can be based on eGFR and either urine albumin/creatine ration or urine-dipstick test with presence of protein.
- Albumin/creatinine ratio < 500 mg/g
- eGFR > 30 ml/min/1,73m2
- Body Mass Index (BMI) ≤ 35 kg/m2
- Able to adhere to dietary regimen
- Fertile women must use safe contraception (oral contraceptive pill, hormonal or copper intrauterine device, vaginal ring, contraceptive implant, transdermal contraceptive patch or contraceptive injections) or abstinence. Excluded from this are postmenopausal woman without menstrual bleeding for at least 12 months before inclusion, surgically sterilized women and women with surgically sterilized partner.
Who cannot join
- • Diagnosis of heart failure, NYHA II-IV
- Diagnosis of liver failure
- Diabetes mellitus (all types)
- Current malignant disease (other than non-melanoma skin cancer)
- Indicators of other aetiologies of CKD than hypertensive kidney injury, e.g. through kidney biopsy or biochemistry.
- Previous kidney transplant recipient
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- History of stroke or transient cerebral ischemic attack
- Current indication of untreated cardiovascular disease, e.g. planned work-up for ischemia.
- History of myocardial infarction, apart from non-STEMI more than 1 year prior to the study, if the subject is currently revascularized and relevantly medicated.
- Organic nitrate treatment Diagnosed secondary hypertension other than renal parenchymal hypertension (i.e. renal artery stenosis, primary hyperaldosteronism, low renin hypertension etc.)
- Pregnancy or lactation
- Alcohol abuse (intake above the recommended guidelines from Danish Health Authorities)
- Conditions treated with medication that investigator finds may interfere with the effect parameters, and cannot be discontinued during the trial (e.g. atrial fibrillation treated with betablockers)
- If, according to the investigator's assessment, the participant is considered unsuitable to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
University Clinic in Nephrology and Hypertension, Gødstrup Regional Hospital and Aarhus University
Herning, 7400
Kezia T McWhan, MD, 004578432390, kezmcw@rm.dk
About this study
The study aims to study the effects of diatery nitrate in patients with hypertension and hypertensive kidney injury.
The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice.
Effect variables will be measured before and after a 2 week treatment. After a washout period of 14 days, the subjects are crossed over to the opposite treatment.
The study is terminated by measuring effect variables after the second treatment period.
Read the detailed description
AIM: We aim to investigate the mechanisms behind the cardiovascular and renal effect of nitrates in patients with hypertension and hypertensive kidney injury.
HYPOTHESIS: Dietary nitrate decreases BP and increases renal blood flow. This is independent of renal function or enhanced during low eGFR due to reduced renal clearance of nitrate.
METHODS: The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice.
Effect variables will be measured before and after a 2 week treatment. After each treatment period effect variables will be measured, including include 24 hour bloodpressure measurment. Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT) is performed only after the intervention periods.
After a washout period of 14 days, the subjects are crossed over to the opposite treatment. The study is terminated by measuring effect variables after the second treatment period.
PERSPECTIVE: The knowledge gained from these studies can lead to improved dietary counselling, which is a promising approach in the treatment of hypertension.
- Conditions
- Hypertension, CKD - Chronic Kidney Disease
- Being tested
- Beetroot Juice - Active, Beetroot juice placebo
- Keywords
- nitrate, hypertension, beetroot
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot Juice - ActiveDietary supplement
Intervention is beetroot juice ("Beet It concentrated beetroot juice shots", James White Drinks Ltd, Ipswich, England) The nitrate content of the juice is standardized. The dose of nitrate will be 70 ml/day corresponding to intake of 6.5 mmol/400 mg of nitrate.
Beetroot juice placeboDietary supplement
The placebo beetroot juice is a corresponding nitrate free beetroot juice, obtained from the manufacturer ("Beet It nitrate depleted shots", James White Drinks Ltd, Ipswich, England.).
The placebo juice appears identical to the nitrate containing juice regarding color and taste.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice (active) | Active comparator | nitrate content: 400 mg Receives: Dietary Supplement: Beetroot Juice - Active |
| Beetroot juice (placebo) | Placebo comparator | nitrate free Receives: Dietary Supplement: Beetroot juice placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 24 h systolic blood pressure
Measured by Mobiograph
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Secondary outcomes (19)
Diastolic blood pressure
Mobil graph with 24 h measurments
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Heart rate
Mobil graph with 24 h measurment
Measured: Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Pulsewave velocity
Mobil graph with 24 h measurment
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Augmentation index
Mobilograph with 24 h measurment
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Vascular resistance
Mobilograph 24 hour measurments
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Reflection index
Mobilograph 24 hour measuments
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Dipping status
Mobilograph 24 hour measurments
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Blood pressure variability
Mobil graph with 24 h measurment
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Unattended office blood pressure
Measured on the examination days after 5 minutes rest 3 times by an autoumated ossilometric device in an undisturbed room. The mean of the tre measurments is used.
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Renal Blood Flow (RBF)
Change in RBF determined by water based PET/CT scans
Measured: Measured on Day 15 of each intervention period
GFR
Change in GFR measured by Tc99m-DTPA clearance
Measured: Measured on Day 15 of each intervention period
Urine concentration of renal tubular transport proteins
Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Vasoactive hormones
Change in plasma levels of aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Measurements of the NO-system
Blood and urine levels of: Nitrite, nitrate, cyclic guanosine monophosphate (cGMP)
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Plasma and urine levels of sodium, potassium, creatinine, urea, uric acid, albumin and osmolality
Measured in blood and urine (24 h collection). Abbsolute and fractional excretions of sodium and potassium and free water clearence will be calculated.
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Body composition measurments from bioimpedance spectroscopy
Fresenius Body composition monitor is used, which estimates the compartments in the bodycomposition:
Extracellular Body Water (L), Total Body Water (L), Intracellular Body Water (L), Overhydration (L)
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Body weight
Patient weight (kg)
Measured: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of the intervention period)
Central Blood pressure
Sphygmocor measurments
Measured: Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Microvascular function
Laser speckle contrast imaging
Measured: Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start8 Dec 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290842
- Sponsor's protocol ID
- KTM-1-2025
- Acronym
- DINO-CKD
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
- ClinicalTrials.gov ID
- NCT07290842
- Acronym / sponsor ID
- DINO-CKD / KTM-1-2025
- Conditions
- Hypertension, CKD - Chronic Kidney Disease
- Keywords
- nitrate, hypertension, beetroot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 18 Dec 2025 (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 study aims to study the effects of diatery nitrate in patients with hypertension and hypertensive kidney injury.
The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice.
Effect variables will be measured before and after a 2 week treatment. After a washout period of 14 days, the subjects are crossed over to the opposite treatment.
The study is terminated by measuring effect variables after the second treatment period.
Detailed description
AIM: We aim to investigate the mechanisms behind the cardiovascular and renal effect of nitrates in patients with hypertension and hypertensive kidney injury.
HYPOTHESIS: Dietary nitrate decreases BP and increases renal blood flow. This is independent of renal function or enhanced during low eGFR due to reduced renal clearance of nitrate.
METHODS: The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice.
Effect variables will be measured before and after a 2 week treatment. After each treatment period effect variables will be measured, including include 24 hour bloodpressure measurment. Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT) is performed only after the intervention periods.
After a washout period of 14 days, the subjects are crossed over to the opposite treatment. The study is terminated by measuring effect variables after the second treatment period.
PERSPECTIVE: The knowledge gained from these studies can lead to improved dietary counselling, which is a promising approach in the treatment of hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice (active) | Active comparator | Dietary Supplement: Beetroot Juice - Activenitrate content: 400 mg |
| Beetroot juice (placebo) | Placebo comparator | Dietary Supplement: Beetroot juice placebonitrate free |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hypertension, treated with a maximum of 2 antihypertensive drugs and unattended office BP < 150/95 mmHg at the screening visit, or newly diagnosed without antihypertensive treatment by 24-hour BP or home BP measurement (above 130/80 or 135/85 respectively), and unattended office BP < 160/100 mmHg.
Key exclusion criteria (14 listed)
- • Diagnosis of heart failure, NYHA II-IV
- Organic nitrate treatment Diagnosed secondary hypertension other than renal parenchymal hypertension (i.e. renal artery stenosis, primary hyperaldosteronism, low renin hypertension etc.)
- Pregnancy or lactation
- Alcohol abuse (intake above the recommended guidelines from Danish Health Authorities)
- Conditions treated with medication that investigator finds may interfere with the effect parameters, and cannot be discontinued during the trial (e.g. atrial fibrillation treated with betablockers)
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 |
|---|---|---|
| Beetroot Juice - ActiveIntervention is beetroot juice ("Beet It concentrated beetroot juice shots", James White Drinks Ltd, Ipswich, England) The nitrate content of the juice is standardized. The dose of nitrate will be 70 ml/day corresponding to intake of 6.5 mmol/400 mg of nitrate. | Dietary supplement | Beetroot juice (active) |
| Beetroot juice placeboThe placebo beetroot juice is a corresponding nitrate free beetroot juice, obtained from the manufacturer ("Beet It nitrate depleted shots", James White Drinks Ltd, Ipswich, England.). The placebo juice appears identical to the nitrate containing juice regarding color and taste. | Dietary supplement | Beetroot juice (placebo) |
Primary outcome
Changes in 24 h systolic blood pressure
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Measured by Mobiograph
19 secondary outcomes
Diastolic blood pressure
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Heart rate
Time frame: Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Pulsewave velocity
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Augmentation index
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Vascular resistance
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Reflection index
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Dipping status
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Blood pressure variability
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Unattended office blood pressure
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Renal Blood Flow (RBF)
Time frame: Measured on Day 15 of each intervention period
GFR
Time frame: Measured on Day 15 of each intervention period
Urine concentration of renal tubular transport proteins
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Vasoactive hormones
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Measurements of the NO-system
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Plasma and urine levels of sodium, potassium, creatinine, urea, uric acid, albumin and osmolality
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Body composition measurments from bioimpedance spectroscopy
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Body weight
Time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of the intervention period)
Central Blood pressure
Time frame: Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Microvascular function
Time frame: Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot Juice - Active in people with Hypertension and CKD - Chronic Kidney Disease, run by Gødstrup Hospital at 1 site in Denmark.
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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kezia T McWhan, MD (004578436580, kezmcw@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 24 h systolic blood pressure (time frame: Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)). 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 18 Dec 2025.