Clinical trial NCT06245382: The Impact of Goode Health Beverage on Markers of Physiological and Neurocognitive Health
Official title: The Impact of Goode Health Beverage on Markers of Physiological and Neurocognitive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Cognitive Decline
Diet, Healthy
Keywords: endothelial function, brain blood flow, cognition
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Individuals will be randomly assigned to either an experimental or a control condition.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Endothelial Function
timeFrame: baseline & following 2 weeks of daily beverage consumption
measure: Neurocognitive Function
timeFrame: baseline & following 2 weeks of daily beverage consumption
measure: Peripheral blood pressure (systolic, diastolic, mean)
timeFrame: baseline & following 2 weeks of daily beverage consumption
measure: Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)
timeFrame: baseline & following 2 weeks of daily beverage consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: UT Arlington - Science and Engineering Innovation and Research Building
state: Texas
city: Arlington
country: United States
facility: UT Arlington
state: Texas
Study officials:
affiliation: University of Texas at Arlington
name: Robert M Brothers, PhD
role: PRINCIPAL_INVESTIGATOR
References: