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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Cognitive Decline; Diet, Healthy
• Intervention / Treatment: Dietary supplement: Goode Health Beverage; Dietary supplement: Vanilla Base Beverage Blend

Detailed Description

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.

1. 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).
2. 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).

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Arlington, Texas, United States, 76019
      • UT Arlington
    • Arlington, Texas, United States, 76019
      • UT Arlington - Science and Engineering Innovation and Research Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goode Health Beverage; Goode Health Beverage that is high in natural ingredients that are high in Polyphenol 3 content and also have anti-inflammatory and antioxidant properties	Dietary supplement: Goode Health Beverage; This is a commercially available beverage powder that is high is healthy ingredients that are believed to be beneficial for physiological health.
Placebo Comparator: Vanilla Base Blend Beverage; The control beverage is similar but it does not contain the same amount of fiber, anti-inflammatory, and/or antioxidant properties (i.e. mainly smaller or no amounts of flax, ginger, cinnamon, turmeric, berberine bergamot, bilberry, black garlic, and green tea).	Dietary supplement: Vanilla Base Beverage Blend; This is a commercially available beverage powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Function	Flow medicated dilation of the brachial artery	baseline & following 2 weeks of daily beverage consumption
Neurocognitive Function	Performance on the NIH Toolbox Cognitive battery	baseline & following 2 weeks of daily beverage consumption
Peripheral blood pressure (systolic, diastolic, mean)	standard blood pressure measures	baseline & following 2 weeks of daily beverage consumption
Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)	assessment of lipid profile	baseline & following 2 weeks of daily beverage consumption

Collaborators and Investigators

• Sponsor: The University of Texas at Arlington
• Investigators: Principal Investigator: Robert M Brothers, PhD, University of Texas at Arlington

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: endothelial function, brain blood flow, cognition
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Cardiovascular Diseases
• Other Study ID Numbers: 2023-0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IDP.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No