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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berry extract intake, then Placebo | Experimental | 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). |
|
| Placebo intake, then Berry extract intake | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berry extract | Dietary Supplement | Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Song-Young Park, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska at Omaha | Omaha | Nebraska | 68182 | United States |
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A total of 18 participants completed this study and participated in both arms (berry extract and placebo) in a randomized crossover study design with a 2 wk washout period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Berry Extract, Then Placebo | Participants first received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg). After a 2 week washout period, they then received a single dose of placebo (tapioca powder). |
| FG001 | Placebo, Then Berry Extract | Participants first received a single dose of placebo (tapioca powder). After a 2 week washout period, they then received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout (2 Weeks) |
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| Second Intervention (1 Day) |
|
n = 18 participants completed the study in a randomized crossover study design
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| ID | Title | Description |
|---|---|---|
| BG000 | Berry Extract, Then Placebo | Participants first received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg). After a 2 week washout period, they then received a single dose of placebo (tapioca powder). |
| BG001 | Placebo, Then Berry Extract |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent dilation | 1 day |
|
2 wk
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Berry Extract Intake | Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain) Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Song-Young Park | University of Nebraska at Omaha | 402-554-3374 | song-youngpark@unomaha.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2018 | Feb 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005638 | Fruit |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Randomized, placebo-controlled, crossover design (1:1)
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Neither the subject nor the investigators were aware of the study assignments, which were assigned by a lab member not directly involved in the measurements of the research.
| Placebo | Other | Placebo (flour capsule) |
|
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 |
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Participants first received a single dose of placebo (tapioca powder). After a 2 week washout period, they then received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body height | Mean | Standard Deviation | centimeters |
|
| Body mass | Mean | Standard Deviation | kilograms |
|
| Body composition (body fat percentage) | Mean | Standard Deviation | percentage of body fat |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | millimeters of mercury | 1 day |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | millimeters of mercury | 1 day |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent | 1 day |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent fatigue | 1 day |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent fatigue | 1 day |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | millimoles per milliliter | 1 day |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | arbitrary units (a.u.) | 1 day |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | arbitrary units (a.u.) | 1 day |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo Intake | Intake of a placebo (flour capsule) Placebo: Placebo (flour capsule) | 0 | 18 | 0 | 18 | 0 | 18 |
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