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Vasodilator

Nitrate Supplementation for Metabolic Syndrome

Phase < 1

Waitlist Available

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 55-75

Individuals with a waist circumference >102 cm (40 in) for men and > 88 cm for women

Must not have

Individuals with visual impairment

Individuals with active cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Summary

This trial tests if drinking beetroot juice can boost brain health in people with metabolic syndrome. #BeetrootJuice #BrainHealth

Who is the study for?

This trial is for adults aged 55-75 with metabolic syndrome, defined by having at least three of these: high triglycerides, low HDL cholesterol, large waist circumference, high blood pressure, or elevated fasting blood glucose. It's open to all genders and ethnicities but excludes smokers, those on nitrates or certain other medications like Viagra or anti-inflammatories, premenopausal women, individuals with active cancer or severe diseases.

What is being tested?

The study tests if drinking beetroot juice can boost brain function and cognition in people with metabolic syndrome. Participants will be randomly given either real beetroot juice (active) or a placebo version without its active ingredients to compare effects.

What are the potential side effects?

While the trial doesn't specify side effects of beetroot juice directly, common ones may include colored stool and urine due to the natural pigments in beets. Beetroot is generally considered safe; however individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 55 and 75 years old.

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My waist is over 40 inches (men) or 34.6 inches (women).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty seeing.

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My cancer is currently active.

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My depression score indicates moderate to severe depression.

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I am premenopausal, as indicated by my recent menstrual cycle.

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I am currently taking anti-inflammatory medication.

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I am taking medication for chest pain.

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I am currently taking medication like Viagra.

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I am currently on hormone replacement therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Cerebral Autoregulation - NIRx (fNIRS/cerebral oxygenation) and finapres (blood pressure) derived waveforms for transfer function analysis

Changes in Neurovascular Coupling - changes in fNIRS signals during the N-back cognitive test

Cognitive Functioning - Change in N-back test performance

Secondary study objectives

Changes in Pulse Wave Velocity - Colin Cardiovascular Profiling System 2000

Taste Profile of Juice (Sweetness, Bitterness, and Sourness) - Questionnaire developed in our lab

Trial Design

2Treatment groups

Experimental Treatment

Group I: Metabolic Syndrome Older Adult - Placebo juice conditionExperimental Treatment1 Intervention

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.

Group II: Metabolic Syndrome Older AdultExperimental Treatment1 Intervention

0 / 10Eligibility criteria met