NCT06245382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

January 29, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

endothelial function, brain blood flow, cognition

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Goode Health Beverage

EXPERIMENTAL

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

Vanilla Base Blend Beverage

PLACEBO COMPARATOR

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

Interventions

Goode Health BeverageDIETARY_SUPPLEMENT

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

Goode Health Beverage
Vanilla Base Beverage BlendDIETARY_SUPPLEMENT

This is a commercially available beverage powder.

Vanilla Base Blend Beverage

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76019, United States

Location

UT Arlington

Arlington, Texas, 76019, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionCognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Robert M Brothers, PhD

    University of Texas at Arlington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
This will be a double-blinded design where the product (experimental of control) will be randomly assigned and given to the participant by a third party individual.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Individuals will be randomly assigned to either an experimental or a control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 7, 2024

Study Start

October 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share IDP.

Locations