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Completed

NCT Number: NCT04312022

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

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Key information

Conditions

Healthy

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Berry extract

Dietary Supplement

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

Placebo

Other

Placebo (flour capsule)

Primary outcomes

  1. Endothelial Function

    Time frame: 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 outcomes

  1. Systolic Blood Pressure

    Time frame: 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.

  2. Diastolic Blood Pressure

    Time frame: 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.

  3. Oxygen Utility Capacity (Tissue Saturation Index)

    Time frame: 1 day

    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.

  4. Exercise Fatigue Index During Leg Extension

    Time frame: 1 day

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

  5. Exercise Fatigue Index During Leg Flexion

    Time frame: 1 day

    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.

  6. Plasma Total Antioxidant Capacity

    Time frame: 1 day

    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.

  7. Oxygenated Hemoglobin

    Time frame: 1 day

    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

  8. Deoxygenated Hemoglobin

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2020
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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