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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Berry extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, placebo-controlled, crossover design (1:1)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berry extract intake<br>Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain) | Dietary Supplement: Berry extract<br>* Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)<br>|
| Placebo Comparator: Placebo intake<br>Intake of a placebo (flour capsule) | Other: Placebo<br>* Placebo (flour capsule)<br>|

What is the study measuring?
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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 percents (%). Higher values represent a better outcome. Scale range for tissue saturation index is approximately 70-100% for most healthy populations. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthocyanin, endothelial function, oxygen, vascular function, blood pressure, antioxidant