Healthy
Conditions
Keywords
anthocyanin, endothelial function, oxygen, vascular function, blood pressure, antioxidant
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.
Interventions
DIETARY_SUPPLEMENTBerry extract
Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
OTHERPlacebo
Placebo (flour capsule)
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Randomized, placebo-controlled, crossover design (1:1)
Eligibility
Sex/Gender
ALL
Age
19 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Function | 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
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | 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. |
| Oxygen Utility Capacity (Tissue Saturation Index) | 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. |
| Exercise Fatigue Index During Leg Extension | 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. |
| Systolic Blood Pressure | 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. |
| Plasma Total Antioxidant Capacity | 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. |
| Oxygenated Hemoglobin | 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 |
| Deoxygenated Hemoglobin | 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 |
| Exercise Fatigue Index During Leg Flexion | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 9 |
| 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). | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Berry Extract, Then Placebo | Placebo, Then Berry Extract | Total |
|---|---|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 4.2 | 24.2 years STANDARD_DEVIATION 4.1 | 24.8 years STANDARD_DEVIATION 4 |
| Body composition (body fat percentage) | 18.3 percentage of body fat STANDARD_DEVIATION 4.4 | 24.1 percentage of body fat STANDARD_DEVIATION 5.4 | 21.2 percentage of body fat STANDARD_DEVIATION 5.5 |
| Body height | 174.06 centimeters STANDARD_DEVIATION 6.1 | 172.4 centimeters STANDARD_DEVIATION 7 | 173.3 centimeters STANDARD_DEVIATION 6.2 |
| Body mass | 76.7 kilograms STANDARD_DEVIATION 9.5 | 76.8 kilograms STANDARD_DEVIATION 13.1 | 76.8 kilograms STANDARD_DEVIATION 10.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Endothelial Function | 11.7 percent dilation | Standard Deviation 2.9 |
| Placebo Intake | Endothelial Function | 8.2 percent dilation | Standard Deviation 3.1 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Deoxygenated Hemoglobin | -0.4 arbitrary units (a.u.) | Standard Deviation 1.3 |
| Placebo Intake | Deoxygenated Hemoglobin | -2.7 arbitrary units (a.u.) | Standard Deviation 8.7 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Diastolic Blood Pressure | 72.8 millimeters of mercury | Standard Deviation 7 |
| Placebo Intake | Diastolic Blood Pressure | 72.4 millimeters of mercury | Standard Deviation 7.4 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Exercise Fatigue Index During Leg Extension | 27.4 percent fatigue | Standard Deviation 11 |
| Placebo Intake | Exercise Fatigue Index During Leg Extension | 25.0 percent fatigue | Standard Deviation 8.6 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Exercise Fatigue Index During Leg Flexion | 24.9 percent fatigue | Standard Deviation 11.2 |
| Placebo Intake | Exercise Fatigue Index During Leg Flexion | 24.8 percent fatigue | Standard Deviation 11.8 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Oxygenated Hemoglobin | 10.1 arbitrary units (a.u.) | Standard Deviation 7.1 |
| Placebo Intake | Oxygenated Hemoglobin | 9.6 arbitrary units (a.u.) | Standard Deviation 8.1 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Oxygen Utility Capacity (Tissue Saturation Index) | 71.5 percent | Standard Deviation 10.4 |
| Placebo Intake | Oxygen Utility Capacity (Tissue Saturation Index) | 64.3 percent | Standard Deviation 24.3 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Plasma Total Antioxidant Capacity | 15.8 millimoles per milliliter | Standard Deviation 9 |
| Placebo Intake | Plasma Total Antioxidant Capacity | 15.0 millimoles per milliliter | Standard Deviation 8.5 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Berry Extract Intake | Systolic Blood Pressure | 110.0 millimeters of mercury | Standard Deviation 10 |
| Placebo Intake | Systolic Blood Pressure | 112.5 millimeters of mercury | Standard Deviation 10.3 |