Blood PressurePhase 2NCT01686282
Blueberry Consumption Improves Vascular Function and Lowers Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension
A Phase 2 study testing Freeze-dried Blueberry Powder in people with Blood Pressure, run by Florida State University at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans have been more concerned about their blood cholesterol levels and dietary cholesterol intakes rather than their overall cardiovascular health risk factors leading to CVD such as hypertension, vascular dysfunction, inadequate… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Freeze-dried Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- Phase
- Phase 2
- 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
- 40 women (1 to 10 years after natural menopause or bilateral oophorectomy) 45-65 years of age.
- Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/90 mm Hg.
Who cannot join
- Blood pressure >160/100 mmHg
- Taking insulin
- Cardiovascular disease
- Active cancer
- Asthma
- Glaucoma
Show all 12Show fewer
- Thyroid disease
- 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
The Department of Nutrition, Food, and Exercise Sciences, Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Daily Incorporation of Blueberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension.
Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans have been more concerned about their blood cholesterol levels and dietary cholesterol intakes rather than their overall cardiovascular health risk factors leading to CVD such as hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and physical activity. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to increased arterial stiffness.
The investigators long-term goal is to provide feasible and effective dietary ways for pre- and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve vascular function and thereby reducing their cardiovascular risk and enhancing the quality of life. Blueberries are a rich source of phenolic compounds and these compounds may play an important role in promoting cardiovascular health. Considering the strong possibility that phytochemicals present in blueberry work additively or synergistically, it would be ideal to investigate the cardioprotective effects of blueberry as a whole. The investigators overall objective to bring forth evidence that blueberry consumption will reduce BP and cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The investigators hypothesize that blueberry supplementation will improve vascular function and will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this study will provide a foundation for disseminating feasible, safe approaches for preventing and combating hypertension at its early stage which does not require drug therapy.
Read the detailed description
The purpose of this study is to examine the effects of 22 grams of freeze-dried blueberry intake on a daily basis for eight weeks in:
The purpose of the study is to examine the effects of 22 grams of freeze-dried blueberry intake on a daily basis for eight weeks on arterial function and blood pressure in postmenopausal women with pre- and stage 1-hypertension. The specific aims of the study are:
- To investigate the extent to which daily consumption of 22 g blueberry drink-mix reduces blood pressure in individuals with pre- and stage 1-hypertension.
- To determine whether daily consumption of 22 g blueberry drink-mix will improve the autonomic control of blood pressure and heart rate in individuals with pre- and stage 1-hypertension.
- To measure serum markers of oxidative stress to determine whether increased antioxidant defense is in part responsible for blueberry's vascular protective effects.
- Conditions
- Blood Pressure
- Being tested
- Freeze-dried Blueberry Powder, Placebo
- Keywords
- Blood pressure, Arterial Stiffness, Blueberry Supplementation, Aortic Blood Pressure, Hypertension, Postmenopausal, Pulse Wave Velocity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried Blueberry PowderDietary supplement
Also called U.S. Highbush Blueberry Council
8 weeks of freeze-dried taken in two doses of 22g each per day.
PlaceboDietary supplement
8 weeks of freeze-dried taken in two doses of 22g each per day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day. Receives: Dietary Supplement: Placebo |
| Blueberry | Experimental | 8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day. Receives: Dietary Supplement: Freeze-dried Blueberry Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
By measuring aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Measured: 8 weeks
Secondary outcomes (6)
Autonomic Control of Blood Pressure
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
Measured: 8 weeks
Autonomic Control of Heart Rate
By measuring heart rate variability at rest and during physiological stress.
Measured: 8 weeks
Endothelial Function
By measuring markers of vascular inflammation (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
Measured: 8 week
Inflammation
By measuring a marker of inflammation (tumor necrosis factor-α [TNF-α]).
Measured: 8 weeks
Oxidative Stress
By measuring markers of oxidative stress (superoxide dismutase [SOD], nitrate/nitrite [NOx], ET-1, angiotensin II, 8-isoprostane, MDA, and oxidized LDL).
Measured: 8 weeks
Arterial Stiffness
By measuring the augmentation index and arterial stiffness at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Measured: 8 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionJan 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 Blood PressureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Principal investigator, Bahram Arjmandi, Florida State University
- Investigators
- Bahram H Arjmandi, PhD, RD, Principal investigator, Florida State UniversityArturo Figueroa, MD, PhD, Principal investigator, Florida State UniversitySarah A Johnson, PhD, RD, CSO, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686282
- Sponsor's protocol ID
- 021259
- Status last verified
- Jan 2015
- First submitted
- 11 Sep 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8.
PubMed 25578927
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Incorporation of Blueberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension.
- ClinicalTrials.gov ID
- NCT01686282
- Acronym / sponsor ID
- 021259
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Arterial Stiffness, Blueberry Supplementation, Aortic Blood Pressure, Hypertension, Postmenopausal, Pulse Wave Velocity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Sep 2012 (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) continues to be the leading cause of death in the U.S. Americans have been more concerned about their blood cholesterol levels and dietary cholesterol intakes rather than their overall cardiovascular health risk factors leading to CVD such as hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and physical activity. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to increased arterial stiffness.
The investigators long-term goal is to provide feasible and effective dietary ways for pre- and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve vascular function and thereby reducing their cardiovascular risk and enhancing the quality of life. Blueberries are a rich source of phenolic compounds and these compounds may play an important role in promoting cardiovascular health. Considering the strong possibility that phytochemicals present in blueberry work additively or synergistically, it would be ideal to investigate the cardioprotective effects of blueberry as a whole. The investigators overall objective to bring forth evidence that blueberry consumption will reduce BP and cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The investigators hypothesize that blueberry supplementation will improve vascular function and will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this study will provide a foundation for disseminating feasible, safe approaches for preventing and combating hypertension at its early stage which does not require drug therapy.
Detailed description
The purpose of this study is to examine the effects of 22 grams of freeze-dried blueberry intake on a daily basis for eight weeks in:
The purpose of the study is to examine the effects of 22 grams of freeze-dried blueberry intake on a daily basis for eight weeks on arterial function and blood pressure in postmenopausal women with pre- and stage 1-hypertension. The specific aims of the study are:
- To investigate the extent to which daily consumption of 22 g blueberry drink-mix reduces blood pressure in individuals with pre- and stage 1-hypertension.
- To determine whether daily consumption of 22 g blueberry drink-mix will improve the autonomic control of blood pressure and heart rate in individuals with pre- and stage 1-hypertension.
- To measure serum markers of oxidative stress to determine whether increased antioxidant defense is in part responsible for blueberry's vascular protective effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day. |
| Blueberry | Experimental | Dietary Supplement: Freeze-dried Blueberry Powder8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40 women (1 to 10 years after natural menopause or bilateral oophorectomy) 45-65 years of age.
- Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/90 mm Hg.
Key exclusion criteria (12 listed)
- Blood pressure >160/100 mmHg
- Taking insulin
- Cardiovascular disease
- Active cancer
- Asthma
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 |
|---|---|---|
| Freeze-dried Blueberry PowderAlso: U.S. Highbush Blueberry Council8 weeks of freeze-dried taken in two doses of 22g each per day. | Dietary supplement | Blueberry |
| Placebo8 weeks of freeze-dried taken in two doses of 22g each per day. | Dietary supplement | Placebo |
Primary outcome
Blood Pressure
Time frame: 8 weeks
By measuring aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
6 secondary outcomes
Autonomic Control of Blood Pressure
Time frame: 8 weeks
Autonomic Control of Heart Rate
Time frame: 8 weeks
Endothelial Function
Time frame: 8 week
Inflammation
Time frame: 8 weeks
Oxidative Stress
Time frame: 8 weeks
Arterial Stiffness
Time frame: 8 Week
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 14 Jan 2015.
- Derived from this study: PubMed 25578927Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8.
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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.
Bahram H Arjmandi, PhD, RD principal investigator
Florida State University
Arturo Figueroa, MD, PhD principal investigator
Florida State University
Sarah A Johnson, PhD, RD, CSO 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 Phase 2 study testing Freeze-dried Blueberry Powder in people with Blood Pressure, 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 2 inclusion and 12 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 14 Jan 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT01686282, 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 14 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.