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

NCT ID: NCT06245382

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-12-31

Brief Summary

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.

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).

Conditions

Cardiovascular Diseases; Hypertension; Cognitive Decline; Diet, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Goode Health Beverage

Intervention Type: 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 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).

Group Type: PLACEBO_COMPARATOR

Vanilla Base Beverage Blend

Intervention Type: DIETARY_SUPPLEMENT

This is a commercially available beverage powder.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Vanilla Base Beverage Blend

This is a commercially available beverage powder.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

• Any food allergy.
• Pregnant women
• Breast feeding
• Allergies to spandex/lycra.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Matthew Brothers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert M Brothers, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Arlington

Locations

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, United States

UT Arlington

Arlington, Texas, United States

Countries

United States

Other Identifiers

2023-0202

Identifier Type: -

Identifier Source: org_study_id