Nitrate-rich beetroot juice to improve brain blood-flow control in cognitive decline

The Neurovascular Coupling as a Target for Cognitive Enhancement in Vascular Cognitive Decline Through an Innovative Nitrate-driven Dietary Supplementation.

This test gives nitrate-rich beetroot juice or a placebo to people with small vessel cerebrovascular disease or diabetes to see if it improves brain blood-flow regulation and thinking skills.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Coimbra (Academic / other)
• Locations: 2 sites (Coimbra and 1 other locations)
• Trial ID: NCT07329647 on ClinicalTrials.gov

What this trial studies

Participants with cerebral small vessel disease or diabetes at high risk for microvascular brain injury are given either nitrate-rich beetroot juice or a placebo and undergo measures of neurovascular coupling, cerebral blood flow, brain imaging, and cognitive testing. The protocol compares physiological and cognitive responses between the active and placebo groups to determine short-term effects of dietary nitrate on brain perfusion and function. Eligible patients must be able to consent and read Portuguese, and common exclusions include other vascular diseases, recent stroke, MRI contraindications, current smoking, or substance abuse. The work is led by investigators at the University of Coimbra and performed at clinical and imaging sites in Coimbra, Portugal.

Who should consider this trial

Good fit: Ideal candidates are adults with a formal diagnosis of cerebral small vessel disease (Age-Related White Matter Changes grades 1–3) or patients with diabetes at high risk for cSVD who can give written informed consent and read Portuguese.

Not a fit: Patients with other vascular diseases, a recent stroke (less than 6 months), MRI contraindications, current smokers, those with alcohol or drug abuse, needle phobia, or intolerance to dietary polyphenol changes are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, nitrate supplementation could improve control of cerebral blood flow and help preserve or improve cognitive function in people with small vessel disease or diabetes.

How similar studies have performed: Preclinical work and some small human studies have shown acute improvements in blood flow and cognitive measures with dietary nitrates, but larger, longer trials are limited.

Eligibility criteria

Inclusion Criteria:

* Formal diagnosis of cerebral small vessel disease (grades 1 to 3 in the Age-Related White Matter Changes Scale as assessed by Computerized Tomography or Magnetic Ressonance Imaging - MRI) and patients at high risk for cerebral small vessel disease with diabetes mellitus;
* Subject has capacity and is capable of giving written informed consent;
* Subject is able to read, comprehend and record information written in Portuguese.

Exclusion Criteria:

* Vascular diseases other than cerebral Small Vessel Disease (cSVD);
* Stroke event less than 6 months ago;
* Unsuitable for MRI scanning because of presence of any standard MRI contraindication (e.g presence of a cardiac pacemaker, other medical implants or devices, or the presence of ferromagnetic metal foreign bodies);
* Needle phobia;
* Inability or intolerance to dietary polyphenol adjustment;
* Current smoker;
* Alcohol abuse, drug abuse or use of drugs affecting cognitive assessment, such as sedatives, hypnotics, nootropic drugs, cholinergic drugs;
* Use of medications that may be contraindicated or interact with the high nitrate diet, such as nitroglycerin or nitrate preparations used for angina, or phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil (Viagral);
* Patients previously diagnosed with dementia;
* Presence of congenital mental retardation and severe neurological and psychiatric diseases;
* Illiterate or severe visual or hearing impairment that may prevent patients from cooperating with cognitive assessment;
* Relevant depression or other unrelated serious mental illness;
* Severe cardiac, pulmonary, renal or hepatic insufficiency;
* Patients who have participated in other interventional clinical studies within the last 3 months, or are participating in other interventional clinical studies.

Where this trial is running

Coimbra and 1 other locations

• Institute for Nuclear Sciences Applied to Health (ICNAS), University of Coimbra — Coimbra, Portugal (Recruiting)
• Unidade de Saúde Local de Coimbra (ULS Coimbra) — Coimbra, Portugal (Recruiting)

Study contacts

• Study coordinator: Miguel Castelo Branco, MD PhD

Conditions Small Vessel Cerebrovascular Disease; Diabete Mellitus