Clinical trial NCT05532423: Nitrate Supplementation and Cerebrovascular and Cognitive Function in Metabolic Syndrome
Official title: Effect of Nitrate Supplementation on Cerebrovascular Function and Cognitive Function in Older Adults With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metabolic Syndrome
Keywords: Cognition
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The design is a single group randomized crossover trial, with individuals with metabolic syndrome receiving both the active nitrate rich juice and the placebo juice, randomized in order.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Functioning - Change in N-back test performance
timeFrame: At Baseline, 90 minutes following drinking the beetroot juice (single 140mL acute dose), 90 minutes following drinking the placebo drink (single 140mL acute dose), and after 4 weeks of daily (70mL) beetroot juice consumption
measure: Cognitive Functioning - Change in N-back test performance
timeFrame: At Baseline, 90 minutes following drinking the beetroot juice (single 140mL acute dose), 90 minutes following drinking the placebo drink (single 140mL acute dose), and after 4 weeks of daily (70mL) beetroot juice consumption
measure: Changes in Cerebral Autoregulation - NIRx (fNIRS/cerebral oxygenation) and finapres (blood pressure) derived waveforms for transfer function analysis
timeFrame: At Baseline, 90 minutes following drinking the beetroot juice (single 140mL acute dose), 90 minutes following drinking the placebo drink (single 140mL acute dose), and after 4 weeks of daily (70mL) beetroot juice consumption
measure: Changes in Neurovascular Coupling - changes in fNIRS signals during the N-back cognitive test
timeFrame: At Baseline, 90 minutes following drinking the beetroot juice (single 140mL acute dose), 90 minutes following drinking the placebo drink (single 140mL acute dose), and after 4 weeks of daily (70mL) beetroot juice consumption
Secondary outcomes:
measure: Changes in Pulse Wave Velocity - Colin Cardiovascular Profiling System 2000
timeFrame: At Baseline, 90 minutes following drinking the beetroot juice (single 140mL acute dose), 90 minutes following drinking the placebo drink (single 140mL acute dose), and after 4 weeks of daily (70mL) beetroot juice consumption
measure: Taste Profile of Juice (Sweetness, Bitterness, and Sourness) - Questionnaire developed in our lab
timeFrame: This will be taken one time, at the last study visit after 4 weeks of juice consumption
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University, Noll Lab
state: Pennsylvania
Study officials:
References: