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

N/ACompletedNCT04312022

University of Nebraska18 enrolled

Overview

The purpose of this study is 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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Berry extractDIETARY_SUPPLEMENT

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

PlaceboOTHER

Placebo (flour capsule)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Nebraska at Omaha

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Endothelial Function

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.

Time frame: 1 day

Secondary Outcomes

Systolic Blood Pressure

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.

Time frame: 1 day

Diastolic Blood Pressure

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.

Time frame: 1 day

Oxygen Utility Capacity (Tissue Saturation Index)

Oxygen utility capacity was measured as tissue saturation index in percent (%). Higher values represent a better outcome. Scale range for tissue saturation index (TSI) is approximately 60-90% for most healthy populations at rest.

Time frame: 1 day

Exercise Fatigue Index During Leg Extension

Index of fatigue during leg extension exercise. A lower value represents a better outcome. Scale range is \~15 - 35% for most healthy populations.

Time frame: 1 day

Exercise Fatigue Index During Leg Flexion

Fatigue index was quantified during isokinetic contraction of the participants dominant leg before and after berry extract and placebo intake using an isokinetic dynamometer. Test consisted of mild resistance at 240°/s to induce and measure muscular fatigue. Fatigue index = (initial peak torque - final peak torque)/initial peak torque x 100). A lower value represents a better outcome. Scale range is \~15 - 35% for most healthy populations.

Data from ClinicalTrials.gov

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