Clinical trial NCT04312022: Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults
Official title: Impacts of a Combined Berry Extract Supplement on Endothelial Function, Blood Pressure, Oxygen Utility Capacity, and Fatigue Index in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: anthocyanin
endothelial function
oxygen
vascular function
blood pressure
antioxidant
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo-controlled, crossover design (1:1)
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Endothelial Function
timeFrame: 1 day
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 1 day
measure: Diastolic Blood Pressure
timeFrame: 1 day
measure: Oxygen Utility Capacity (Tissue Saturation Index)
timeFrame: 1 day
measure: Exercise Fatigue Index During Leg Extension
timeFrame: 1 day
measure: Exercise Fatigue Index During Leg Flexion
timeFrame: 1 day
measure: Plasma Total Antioxidant Capacity
timeFrame: 1 day
measure: Oxygenated Hemoglobin
timeFrame: 1 day
measure: Deoxygenated Hemoglobin
timeFrame: 1 day
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska at Omaha
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Song-Young Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: