Nitrate Supplementation and Cerebrovascular and Cognitive Function in Metabolic Syndrome

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Early Phase 1

Conditions: Metabolic Syndrome

Treatments: Drug: beetroot juice - Placebo; Drug: Beetroot Juice - Active

Study type: Interventional

Funder types: Other

Identifiers

NCT05532423

STUDY00020830

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

MetS classification according to NCEP III definition - MetS group only ... at least 3 of the 5 components Individuals with a waist circumference >102 cm (40 in) for men > 88 cm for women Triglycerides ≥150 mg/dL HDL cholesterol ≤ 50 mg/dL for women and ≤ 40 mg/dL for men Blood pressure ≥130/85 mmHg Fasting blood glucose ≥100 mg/dL Age 55-75 Men and women All races and ethnicities

Exclusion criteria

1. Individuals with any overt cardiovascular, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s).

2. Premenopausal women - indicated by mention of last menstrual cycle

3. Individuals with active cancer

4. Individuals with moderate/severe depressive disorder as indicated by BDI-II scores (BDI-II score >14)

5. Individuals with cognitive impairment as indicated by the MMSE (score on the MMSE < 24)

6. Individuals with visual impairment

7. Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)

8. Individuals taking hormone replacement

9. Taking following an of the following medications:

   1. nitrates (e.g. nitroglycerin) for angina
   2. phosphodiesterase inhibitors (e.g., Viagra)
   3. anti-Inflammatory drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Metabolic Syndrome Older Adult

Experimental group

Description:

Participants with metabolic syndrome will be drinking nitrate rich beetroot juice from the James White Beet It company. Participants will drink one dose of 140mL beetroot juice for two visits of either a nitrate rich juice or a nitrate depleted placebo drink. Both drinks taste and smell the same, just with the active component removed. Following these visits, participants will drink 70ml of nitrate rich beetroot juice daily for 4 weeks to investigate long term effects of the juice on study outcomes.

Treatment:

Drug: Beetroot Juice - Active

Metabolic Syndrome Older Adult - Placebo juice condition

Experimental group

Description:

Participants with metabolic syndrome will be drinking nitrate rich beetroot juice from the James White Beet It company. Participants will drink one dose of 140mL beetroot juice for two visits of either a nitrate rich juice or a nitrate depleted placebo drink. Both drinks taste and smell the same, just with the active component removed. Following these visits, participants will drink 70ml of nitrate rich beetroot juice daily for 4 weeks to investigate long term effects of the juice on study outcomes.

Treatment:

Drug: beetroot juice - Placebo