HealthyNCT04312022
Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults
A study testing Berry extract in people with Healthy, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Berry extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2018to 13 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- otherwise healthy adult
Who cannot join
- cardiovascular disease
- neurological disorder
- metabolic disorder
- respiratory disorder
- renal diseases
- musculoskeletal injury
Show all 10Show fewer
- bleeding disorder
- allergy to fruit
- pregnant/breast feeding
- taking daily medication (prescription or over-the-counter)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska at Omaha
Omaha, Nebraska, 68182
About this study
Official title: Impacts of a Combined Berry Extract Supplement on Endothelial Function, Blood Pressure, Oxygen Utility Capacity, and Fatigue Index in Healthy Young Adults
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Berry extract, Placebo
- Keywords
- anthocyanin, endothelial function, oxygen, vascular function, blood pressure, antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berry extractDietary supplement
Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
PlaceboOther
Placebo (flour capsule)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Berry extract |
| 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start4 Nov 2018
- Primary completion29 Mar 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, crossover design (1:1)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Song-Young Park, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312022
- Sponsor's protocol ID
- 0436-18-FB
- Status last verified
- Feb 2024
- First submitted
- 13 Mar 2020
- Last updated
- 6 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of a Combined Berry Extract Supplement on Endothelial Function, Blood Pressure, Oxygen Utility Capacity, and Fatigue Index in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT04312022
- Acronym / sponsor ID
- 0436-18-FB
- Conditions
- Healthy
- Keywords
- anthocyanin, endothelial function, oxygen, vascular function, blood pressure, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 4 Nov 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Posted 6 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, crossover design (1:1)
| Arm | Type | Receives |
|---|---|---|
| Berry extract intake, then Placebo | Experimental | Dietary Supplement: Berry extractParticipants 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 | Other: PlaceboParticipants 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). |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- otherwise healthy adult
Key exclusion criteria (10 listed)
- cardiovascular disease
- neurological disorder
- metabolic disorder
- respiratory disorder
- renal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berry extractBerry extract supplement (hawthorn berry extract, tart cherry extract, bromelain) | Dietary supplement | Berry extract intake, then Placebo |
| PlaceboPlacebo (flour capsule) | Other | Placebo intake, then Berry extract intake |
Primary outcome
Endothelial Function
Time frame: 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.
8 secondary outcomes
Systolic Blood Pressure
Time frame: 1 day
Diastolic Blood Pressure
Time frame: 1 day
Oxygen Utility Capacity (Tissue Saturation Index)
Time frame: 1 day
Exercise Fatigue Index During Leg Extension
Time frame: 1 day
Exercise Fatigue Index During Leg Flexion
Time frame: 1 day
Plasma Total Antioxidant Capacity
Time frame: 1 day
Oxygenated Hemoglobin
Time frame: 1 day
Deoxygenated Hemoglobin
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song-Young Park, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berry extract in people with Healthy, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.