Pre-hypertensionCSCBPNCT01190319
Study: Effects of Strawberries on Blood Pressure
A study testing Strawberry Beverage in people with Pre-hypertension, run by University of California, Davis at 1 site in United States.
Trial summary
The specific aim of the study is to determine whether a freeze dried powder provided by the California Strawberries Commission, can reduce blood pressure in patients with pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Pre-hypertension
- What is being tested?
- Strawberry Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-hypertensive men and women (JNC 7 [The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure] criteria) between the ages of 25 and 65 years who have no clinical evidence/history of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease.
Who cannot join
- Subjects who:
- are taking over the counter anti-oxidant supplements,
- are taking prescription medications that may interfere with study procedures or endpoints,
- have unusual dietary habits (eg., pica),
- are actively losing weight or trying to lose weight,
- are addicted to drugs or alcohol,
Show all 10Show fewer
- present with significant psychiatric or neurological disturbances,
- have known allergies to strawberry, will be excluded from participating in this study.
- Patients known to have glaucoma
- Pregnant and/or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis (Ragle Hall)
Davis, California, 95616
About this study
Official title: Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension
The specific aim of the study is to determine whether a freeze dried powder provided by the California Strawberries Commission, can reduce blood pressure in patients with pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).
Read the detailed description
Primarily, we would like to find out whether freeze dried strawberry powder lowers blood pressure. In addition we would like to know if the strawberry alters the subject's blood cholesterol and the ability of the subject's blood vessels to relax.
- Conditions
- Pre-hypertension
- Being tested
- Strawberry Beverage, Placebo
- Keywords
- blood pressure, strawberry, fruit phenolics, LDL oxidation, Flow mediated dilation (FMD)
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strawberry BeverageOther
Also called Strawberry powder made from a mix of California strawberries.
Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder
PlaceboOther
Also called Beverage
Placebo beverage, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Beverage | Placebo comparator | The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols. Receives: Other: Placebo |
| Strawberry Beverage | Experimental | The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols. Receives: Other: Strawberry Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: 8 weeks
Secondary outcomes (2)
Change in low density lipoprotein (LDL) oxidation
Measured: 8 weeks
Change in flow mediated dilation (FMD)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionOct 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- California Strawberry Commission
- Responsible party
- Sponsor
- Investigators
- Chulani T Kappagoda, MD, Principal investigator, University of California, DavisBritt Burton-Freeman, Ph.D, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190319
- Sponsor's protocol ID
- 200715153
- Acronym
- CSCBP
- Status last verified
- Jul 2017
- First submitted
- 20 Oct 2009
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension
- ClinicalTrials.gov ID
- NCT01190319
- Acronym / sponsor ID
- CSCBP / 200715153
- Conditions
- Pre-hypertension
- Keywords
- blood pressure, strawberry, fruit phenolics, LDL oxidation, Flow mediated dilation (FMD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Strawberry Commission
- Study start
- Sep 2007 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of the study is to determine whether a freeze dried powder provided by the California Strawberries Commission, can reduce blood pressure in patients with pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).
Detailed description
Primarily, we would like to find out whether freeze dried strawberry powder lowers blood pressure. In addition we would like to know if the strawberry alters the subject's blood cholesterol and the ability of the subject's blood vessels to relax.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Beverage | Placebo comparator | Other: PlaceboThe placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols. |
| Strawberry Beverage | Experimental | Other: Strawberry BeverageThe strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-hypertensive men and women (JNC 7 [The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure] criteria) between the ages of 25 and 65 years who have no clinical evidence/history of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease.
Key exclusion criteria (10 listed)
- Subjects who:
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 |
|---|---|---|
| Strawberry BeverageAlso: Strawberry powder made from a mix of California strawberries.Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder | Other | Strawberry Beverage |
| PlaceboAlso: BeveragePlacebo beverage, 8 weeks | Other | Placebo Beverage |
Primary outcome
Change in blood pressure
Time frame: 8 weeks
2 secondary outcomes
Change in low density lipoprotein (LDL) oxidation
Time frame: 8 weeks
Change in flow mediated dilation (FMD)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
Related trials for Pre-hypertension
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Chulani T Kappagoda, MD principal investigator
University of California, Davis
Britt Burton-Freeman, Ph.D principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strawberry Beverage in people with Pre-hypertension, run by University of California, Davis 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 13 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in blood pressure (time frame: 8 weeks). 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 13 Jul 2017.