NCT05532423

Nitrate Supplementation and Cerebrovascular and Cognitive Function in Metabolic Syndrome

Effect of Nitrate Supplementation on Cerebrovascular Function and Cognitive Function in Older Adults With Metabolic Syndrome

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if beetroot juice consumption can improve cognitive performance and brain vascular function in individuals with metabolic syndrome

Detailed description

Metabolic syndrome is a preclinical state that is related to increased risk of cardiovascular and metabolic disease. The purpose of this study is to determine if beetroot juice consumption can improve cognitive performance and brain vascular function in individuals with metabolic syndrome. The first part of this study will aim to determine if people with metabolic syndrome present with poorer brain vascular function and cognitive performance relative to older adults without metabolic syndrome. The second part of this study aims to determine whether brain vascular functions and cognitive function can be improved with beetroot juice. Cognitive function is highly related to the ability of the brain to deliver blood to specific regions of the brain. The brain has many blood vessels and relies on a healthy and intact vascular system to optimally perform. With aging and disease risk factors that relate to metabolic syndrome, cognition and brain function and structure decline at a more rapid pace. These changes may directly impact quality of life, financial burden, and independence. Therefore, determining the cognitive and brain functional changes that occur due to metabolic syndrome is an important clinical and scientific question. This research study will assess whether dietary nitrate, in the form of beetroot juice, can improve brain blood vessel function and cognition in adults with metabolic syndrome. Beetroot juice has a high content of dietary nitrate, which has known beneficial effects on blood vessel function and blood pressure. With aging and disease risk factors, you lose the ability to dilate the blood vessels, reducing how much blood can get to the brain. Providing dietary nitrate in the form of beetroot juice may help improve blood vessel dilation and cognitive function in individuals with metabolic disease risk factors. Additionally, intervening during metabolic syndrome, before disease progresses to cardiovascular disease and diabetes, is optimal to minimize the long-term effects on cognition and brain health.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Beetroot Juice - Active	Participants with Metabolic syndrome will drink 140mL of organic nitrate rich beetroot juice from the James White Beet It Company. This juice will be the active juice, meaning it has the high nitrate content that is of interest. This drink will be given two 70 mL bottles of the juice that will be blinded to them and investigators.
DRUG	beetroot juice - Placebo	Participants with Metabolic syndrome will drink 140mL of organic nitrate rich beetroot juice from the James White Beet It Company. This drink will be the placebo drink, which means all of the nitrate has been extracted, however it tastes and smells the same as the active drink. This drink will be given two 70 mL bottles of the juice that will be blinded to them and investigators.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2022-09-08
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study