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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mcbranco@fmed.uc.pt
• Phone: +351 239488510

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.