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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Berry extract; Other: Placebo

Detailed Description

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
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68182
      • University of Nebraska at Omaha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Berry extract intake, then Placebo; Participants received a single dose of berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain). After a washout period of 2 weeks, they then received a single dose of the placebo (flour capsule).	Dietary supplement: Berry extract; Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
Placebo Comparator: Placebo intake, then Berry extract intake; Participants received a single dose of placebo (flour capsule). After a washout period of 2 weeks, they then received a single dose of berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain).	Other: Placebo; Placebo (flour capsule)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	1 day
Plasma Total Antioxidant Capacity	Total antioxidant capacity assessed from the venous blood (plasma). A higher value represents a better outcome. Scale range is 10 - 20 millimoles per milliliter for most healthy populations.	1 day
Oxygenated Hemoglobin	Oxygenated hemoglobin was measured in arbitrary units (a.u.). Higher values represent a better outcome. Scale range for oxygenated hemoglobin is ~5-15 a.u. in healthy populations	1 day
Deoxygenated Hemoglobin	Deoxygenated hemoglobin was measured in arbitrary units (a.u.). Lower values represent a better outcome. Scale range for deoxygenated hemoglobin is ~ - 5-5 in healthy populations	1 day

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Song-Young Park, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2018
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): June 13, 2019

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: blood pressure; oxygen; vascular function; antioxidant; anthocyanin; endothelial function
• Other Study ID Numbers: 0436-18-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No