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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245382
• Other study ID #: 2023-0202
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: The University of Texas at Arlington
• Contact: Robert M Brothers, PhD
• Phone: 8172723156
• Email: matthew.brothers[@]uta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognitive Decline
• Cognitive Dysfunction
• Diet, Healthy
• Hypertension

Intervention

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.
• Vanilla Base Beverage Blend
This is a commercially available beverage powder.

Locations

Country	Name	City	State
United States	UT Arlington	Arlington	Texas
United States	UT Arlington - Science and Engineering Innovation and Research Building	Arlington	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

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