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NCT04312022

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

Completed NA Results posted Last updated 6 February 2024
What this trial tests

NA trial testing Berry extract in Healthy in 18 participants. Completed in 13 June 2019.

Timeline
4 November 2018
Primary endpoint
29 March 2019
13 June 2019

Quick facts

Lead sponsorUniversity of Nebraska
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposeother
Enrollment18
Start date4 November 2018
Primary completion29 March 2019
Estimated completion13 June 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska

Who can join

Adults 19 to 35, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Endothelial Function Primary · 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.

GroupValue95% CI
Berry Extract Intake11.7± 2.9
Placebo Intake8.2± 3.1
Systolic Blood Pressure Secondary · 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.

GroupValue95% CI
Berry Extract Intake110.0± 10.0
Placebo Intake112.5± 10.3
Diastolic Blood Pressure Secondary · 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.

GroupValue95% CI
Berry Extract Intake72.8± 7.0
Placebo Intake72.4± 7.4
Oxygen Utility Capacity (Tissue Saturation Index) Secondary · 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.

GroupValue95% CI
Berry Extract Intake71.5± 10.4
Placebo Intake64.3± 24.3
Exercise Fatigue Index During Leg Extension Secondary · 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.

GroupValue95% CI
Berry Extract Intake27.4± 11.0
Placebo Intake25.0± 8.6
Exercise Fatigue Index During Leg Flexion Secondary · 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.

GroupValue95% CI
Berry Extract Intake24.9± 11.2
Placebo Intake24.8± 11.8
Plasma Total Antioxidant Capacity Secondary · 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.

GroupValue95% CI
Berry Extract Intake15.8± 9.0
Placebo Intake15.0± 8.5
Oxygenated Hemoglobin Secondary · 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

GroupValue95% CI
Berry Extract Intake10.1± 7.1
Placebo Intake9.6± 8.1
Deoxygenated Hemoglobin Secondary · 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

GroupValue95% CI
Berry Extract Intake-0.4± 1.3
Placebo Intake-2.7± 8.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other University of Nebraska trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04312022.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing