Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT04312022

Collaborator

(none)

Enrollment

Location

Arms

7.3

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There are several proposed mechanisms that are thought to contribute to the development of cardiovascular diseases. Although the process is extremely complex, it is well-accepted that elevated levels of reactive oxygen species (ROS) production and inflammation contribute to the systemic vascular dysfunction in cardiovascular diseases. These factors often partially contribute to endothelial dysfunction, elevated blood pressure, reduced oxygen utility capacity, and reduced muscle function. Therefore, by reducing ROS and inflammation, there may be protective effects against vascular dysfunction and thus protection against cardiovascular disease manifestation. Intake of natural anthocyanins and polyphenols derived from fruits and vegetables has been shown to reduce excessive ROS and inflammation in several populations.

Therefore, the purpose of this study was to investigate the impacts of a combined berry extract supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in healthy young adults.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Berry extract Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, placebo-controlled, crossover design (1:1)Randomized, placebo-controlled, crossover design (1:1)

Masking:

Double (Participant, Investigator)

Masking Description:

Neither the subject nor the investigators were aware of the study assignments, which were assigned by a lab member not directly involved in the measurements of the research.

Primary Purpose:

Other

Official Title:

Impacts of a Combined Berry Extract Supplement on Endothelial Function, Blood Pressure, Oxygen Utility Capacity, and Fatigue Index in Healthy Young Adults

Actual Study Start Date :

Nov 4, 2018

Actual Primary Completion Date :

Mar 29, 2019

Actual Study Completion Date :

Jun 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Berry extract intake Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)	Dietary Supplement: Berry extract Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
Placebo Comparator: Placebo intake Intake of a placebo (flour capsule)	Other: Placebo Placebo (flour capsule)

Arm

Intervention/Treatment

Experimental: Berry extract intake

Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)

Dietary Supplement: Berry extract

Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)

Placebo Comparator: Placebo intake

Intake of a placebo (flour capsule)

Other: Placebo

Placebo (flour capsule)

Outcome Measures

Primary Outcome Measures

Endothelial function [1 day]
Endothelial function was measured using flow-mediated dilation in percents (%). A higher value represents a better outcome. Scale range for endothelial function is approximately 8-12% for healthy populations.

Secondary Outcome Measures

Systolic blood pressure [1 day]
Systolic blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 110-129 for most healthy populations.
Diastolic blood pressure [1 day]
Diastolic blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 70-79 mmHg for most healthy populations.
Oxygen utility capacity (tissue saturation index) [1 day]
Oxygen utility capacity was measured as tissue saturation index in percents (%). Higher values represent a better outcome. Scale range for tissue saturation index is approximately 70-100% for most healthy populations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

otherwise healthy adult

Exclusion Criteria:

cardiovascular disease
neurological disorder
metabolic disorder
respiratory disorder
renal diseases
musculoskeletal injury
bleeding disorder
allergy to fruit
pregnant/breast feeding
taking daily medication (prescription or over-the-counter)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Nebraska at Omaha	Omaha	Nebraska	United States	68182

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Song-Young Park, Assistant Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT04312022

Other Study ID Numbers:

436-19

First Posted:

Mar 17, 2020

Last Update Posted:

Nov 27, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Song-Young Park, Assistant Professor, University of Nebraska

Study Results

No Results Posted as of Nov 27, 2020