HypertensionNCT02099578
The Effects of Strawberries on Blood Pressure in Postmenopausal Women
A study testing 25 g of Freeze-dried Strawberry Powder and 50 g of Freeze-dried Strawberry Powder in people with Hypertension and Cardiovascular Diseases, run by Florida State University at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive and hypertensive. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- What is being tested?
- 25 g of Freeze-dried Strawberry Powder and 50 g of Freeze-dried Strawberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2014
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women (1 to 10 years after natural menopause or bilateral oophorectomy)
- 45-65 years of age
- Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/100 mm Hg
- BMI > 25 but < 40 kg/m2
Who cannot join
- Seated blood pressure ≤ 129/84 or ≥160/101 mmHg
- Type I Diabetes
- Cardiovascular disease
- Active cancer
- Glaucoma
- Thyroid disease
Show all 11Show fewer
- Kidney disease
- Liver disease
- Pancreatic disease
- Enrollment in a weight loss program
- Heavy smokers (>20 cigarettes per day)
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Daily Incorporation of Strawberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Prehypertension
Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive and hypertensive. In addition, the prevalence of hypertension is associated with aging in both genders; however, the increase in blood pressure (BP) in women after menopause exceeds that of men.
The development of effective and safe strategies to improve vascular function is of significance as it can have a great impact on quality of life, productivity and economic burden for the affected populations. One such alternative would be to introduce into the diet food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term goal of the investigators is to provide feasible and effective dietary ways for postmenopausal women to improve their vascular function and quality of life.
Read more
Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks third among all fruits and vegetables. Hence, the purpose of this study is to bring forth evidence that incorporation of strawberries into the diet will reduce blood pressure and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.
Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85 mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three groups:
- 25 g freeze-dried strawberry powder;
- 50 g freeze-dried strawberry powder; or
- placebo powder. Participants will be asked to consume the supplements for 8-weeks. Medical history, medication use, dietary intake, and physical activity will be assessed at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of cardiovascular function as well as oxidative stress and inflammation will be measured.
The investigators hypothesize that regular consumption of strawberry will improve cardiovascular function, decrease BP and blood markers of oxidative stress as well as inflammation. Investigators also expect the findings of this study to provide a foundation for further studies to examine the effects of long-term incorporation of strawberry into the diet and the integrity of cardiovascular system.
- Conditions
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- Being tested
- 25 g of Freeze-dried Strawberry Powder, 50 g of Freeze-dried Strawberry Powder, Placebo Powder
- Keywords
- Blood pressure, Arterial stiffness, Pulse wave velocity, Strawberries, Endothelial function, Oxidative stress, Postmenopausal women
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 g of Freeze-dried Strawberry PowderDietary supplement
Also called California Strawberry Commission
Participants will be given one packet of 25 g of freeze-dried strawberry powder and one packet of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
50 g of Freeze-dried Strawberry PowderDietary supplement
Also called California Strawberry Commission
Participants will be given two packets of 25 g of freeze-dried strawberry powder and asked to consume one packet in the morning and one at night.
Placebo PowderDietary supplement
Also called California Strawberry Commission
Participants will be given two packets of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks Receives: Dietary Supplement: Placebo Powder |
| 25 g of Freeze-dried Strawberry Powder | Active comparator | Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks Receives: Dietary Supplement: 25 g of Freeze-dried Strawberry Powder; Dietary Supplement: Placebo Powder |
| 50 g of Freeze-dried Strawberry Powder | Experimental | Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks Receives: Dietary Supplement: 50 g of Freeze-dried Strawberry Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Measured: 8 weeks
Secondary outcomes (4)
Arterial Stiffness
By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Measured: 8 weeks
Endothelial function
By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
Measured: 8 weeks
Oxidative Stress
By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein).
Measured: 8 weeks
Inflammation
By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein).
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 posted31 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- California Strawberry Commission
- Responsible party
- Principal investigator, Bahram Arjmandi, Florida State University
- Investigators
- Bahram H Arjmandi, PhD, RD, Principal investigator, Florida State UniversityArturo Figueroa, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099578
- Sponsor's protocol ID
- 2013.11762
- Status last verified
- Dec 2016
- First submitted
- 26 Mar 2014
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Feresin RG, Johnson SA, Pourafshar S, Campbell JC, Jaime SJ, Navaei N, Elam ML, Akhavan NS, Alvarez-Alvarado S, Tenenbaum G, Brummel-Smith K, Salazar G, Figueroa A, Arjmandi BH. Impact of daily strawberry consumption on blood pressure and arterial stiffness in pre- and stage 1-hypertensive postmenopausal women: a randomized controlled trial. Food Funct. 2017 Nov 15;8(11):4139-4149. doi: 10.1039/c7fo01183k.
PubMed 29099521
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Incorporation of Strawberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Prehypertension
- ClinicalTrials.gov ID
- NCT02099578
- Acronym / sponsor ID
- 2013.11762
- Conditions
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- Keywords
- Blood pressure, Arterial stiffness, Pulse wave velocity, Strawberries, Endothelial function, Oxidative stress, Postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- California Strawberry Commission
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Mar 2014 (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.
Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive and hypertensive. In addition, the prevalence of hypertension is associated with aging in both genders; however, the increase in blood pressure (BP) in women after menopause exceeds that of men.
The development of effective and safe strategies to improve vascular function is of significance as it can have a great impact on quality of life, productivity and economic burden for the affected populations. One such alternative would be to introduce into the diet food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term goal of the investigators is to provide feasible and effective dietary ways for postmenopausal women to improve their vascular function and quality of life.
Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks third among all fruits and vegetables. Hence, the purpose of this study is to bring forth evidence that incorporation of strawberries into the diet will reduce blood pressure and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.
Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85 mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three groups:
- 25 g freeze-dried strawberry powder;
- 50 g freeze-dried strawberry powder; or
- placebo powder. Participants will be asked to consume the supplements for 8-weeks. Medical history, medication use, dietary intake, and physical activity will be assessed at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of cardiovascular function as well as oxidative stress and inflammation will be measured.
The investigators hypothesize that regular consumption of strawberry will improve cardiovascular function, decrease BP and blood markers of oxidative stress as well as inflammation. Investigators also expect the findings of this study to provide a foundation for further studies to examine the effects of long-term incorporation of strawberry into the diet and the integrity of cardiovascular system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Dietary Supplement: Placebo PowderFreeze-dried placebo powder - two doses of 25 g/day for 8 weeks |
| 25 g of Freeze-dried Strawberry Powder | Active comparator | Dietary Supplement: 25 g of Freeze-dried Strawberry Powder, Dietary Supplement: Placebo PowderFreeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks |
| 50 g of Freeze-dried Strawberry Powder | Experimental | Dietary Supplement: 50 g of Freeze-dried Strawberry PowderFreeze-dried strawberry powder - two doses of 25 g/day for 8 weeks |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women (1 to 10 years after natural menopause or bilateral oophorectomy)
- 45-65 years of age
- Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/100 mm Hg
- BMI > 25 but < 40 kg/m2
Key exclusion criteria (11 listed)
- Seated blood pressure ≤ 129/84 or ≥160/101 mmHg
- Type I Diabetes
- Cardiovascular disease
- Active cancer
- Glaucoma
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 |
|---|---|---|
| 25 g of Freeze-dried Strawberry PowderAlso: California Strawberry CommissionParticipants will be given one packet of 25 g of freeze-dried strawberry powder and one packet of 25 g of placebo powder and asked to consume one packet in the morning and one at night. | Dietary supplement | 25 g of Freeze-dried Strawberry Powder |
| 50 g of Freeze-dried Strawberry PowderAlso: California Strawberry CommissionParticipants will be given two packets of 25 g of freeze-dried strawberry powder and asked to consume one packet in the morning and one at night. | Dietary supplement | 50 g of Freeze-dried Strawberry Powder |
| Placebo PowderAlso: California Strawberry CommissionParticipants will be given two packets of 25 g of placebo powder and asked to consume one packet in the morning and one at night. | Dietary supplement | 25 g of Freeze-dried Strawberry Powder, Control Group |
Primary outcome
Blood Pressure
Time frame: 8 weeks
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
4 secondary outcomes
Arterial Stiffness
Time frame: 8 weeks
Endothelial function
Time frame: 8 weeks
Oxidative Stress
Time frame: 8 weeks
Inflammation
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 16 Dec 2016.
- Derived from this study: PubMed 29099521Feresin RG, Johnson SA, Pourafshar S, Campbell JC, Jaime SJ, Navaei N, Elam ML, Akhavan NS, Alvarez-Alvarado S, Tenenbaum G, Brummel-Smith K, Salazar G, Figueroa A, Arjmandi BH. Impact of daily strawberry consumption on blood pressure and arterial stiffness in pre- and stage 1-hypertensive postmenopausal women: a randomized controlled trial. Food Funct. 2017 Nov 15;8(11):4139-4149. doi: 10.1039/c7fo01183k.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Bahram H Arjmandi, PhD, RD principal investigator
Florida State University
Arturo Figueroa, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25 g of Freeze-dried Strawberry Powder and 50 g of Freeze-dried Strawberry Powder in people with Hypertension and Cardiovascular Diseases, run by Florida State University 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 4 inclusion and 11 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 16 Dec 2016. 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?
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?
On the ClinicalTrials.gov record for NCT02099578, which also lists 1 linked publication.
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 16 Dec 2016.