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Completed

NCT Number: NCT06245382

The Impact of Goode Health Beverage on Markers of Physiological and Neurocognitive Health

The overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Good Health beverage on indices of physiological and neurocognitive health.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Arlington, Arlington, Texas, United States

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About this study

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality and affects all individuals. There are many primary risk factors for CVD with some of the primary causes including hypertension, hypercholesteremia, atherosclerosis, and type 2 diabetes mellitus. Furthermore, the rise in the prevalence of various neurocognitive conditions and cerebral vascular diseases including cognitive dysfunction, dementia, stroke, and Alzheimer's disease requires additional attention from a research perspective. While the reasons contributing to CVD and neurocognitive complications/cerebral vascular diseases, is multifactorial, a common link is impaired vascular function.

A hallmark of impaired vascular function is elevated arterial stiffness and a decrease in the vasodilator capacity in the brain and periphery. Reduced nitric oxide (NO) bioavailability, due to elevated oxidative stress and systemic inflammation is implicated as a primary contributing factor for these attenuated vasodilatory responses. Therefore, it is reasonable to speculate that an approach targeting these pathways could abolish or minimize this elevated risk. One such approach could be increased dietary consumption of a naturally based product that is high in polyphenol content and ingredients that are well-known to have beneficial effects on oxidative stress, inflammation, blood lipids etc. In turn this would be expected to have beneficial outcomes on various biomarkers associated with peripheral and cerebral vascular health including, cholesterol, lipid profile, insulin sensitivity/type II diabetes, cognitive health, arterial stiffness, blood pressure, and NO bioavailability and subsequently vascular function/health. Specifically, the Goode Health Super Food Smoothie Blend is a product that we are interested in investigating in this proposal.

  • Primary Aim - The primary endpoint is the effect of increased daily consumption of the Good Health beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include cognitive function, central and peripheral arterial blood pressure, cerebral and peripheral blood vessel function/health, and blood biomarkers (e.g., indices of inflammation, oxidative stress, insulin resistance/diabetes risk, and lipid profile).
  • Secondary Aim - A secondary endpoint is the effect of daily consumption of the Good Health beverage on the following variables: waist circumference, body weight, and body mass index (BMI).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women who are between the ages of 18-55

Exclusion criteria

  • Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then we may still opt to proceed with data collection.
  • Any food allergy.
  • Pregnant women
  • Breast feeding
  • Allergies to spandex/lycra.

Treatment and study plan

Goode Health Beverage

Dietary Supplement

This is a commercially available beverage powder that is high is healthy ingredients that are believed to be beneficial for physiological health.

Vanilla Base Beverage Blend

Dietary Supplement

This is a commercially available beverage powder.

Primary outcomes

  1. Endothelial Function

    Time frame: baseline & following 2 weeks of daily beverage consumption

    Flow medicated dilation of the brachial artery

  2. Neurocognitive Function

    Time frame: baseline & following 2 weeks of daily beverage consumption

    Performance on the NIH Toolbox Cognitive battery

  3. Peripheral blood pressure (systolic, diastolic, mean)

    Time frame: baseline & following 2 weeks of daily beverage consumption

    standard blood pressure measures

  4. Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)

    Time frame: baseline & following 2 weeks of daily beverage consumption

    assessment of lipid profile

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Registry information

Official study title

The Impact of Goode Health Beverage on Markers of Physiological and Neurocognitive

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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