MenopauseNCT03370991
Blueberries for Improving Vascular Endothelial Function in Postmenopausal Women With Elevated Blood Pressure
A study testing Blueberry Powder in people with Menopause and Elevated Blood Pressure, run by Colorado State University at 1 site in United States.
Trial summary
Postmenopausal women are at an increased risk of developing cardiovascular disease (CVD) largely due to accelerated aging-related modifications to vascular health following menopause. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause, Elevated Blood Pressure, Hypertension
- What is being tested?
- Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2017to 30 Sep 2021
- 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
- Aged 45-65 years
- Postmenopausal women (≥ 1 years postmenopausal; natural or surgical menopause; confirmed by measurement of estradiol at a level < 30 pg/mL and follicle-stimulating hormone at a level ≥ 30 mIU/mL)
- Elevated or stage 1-HTN (confirmed as resting seated systolic blood pressure < 120 or ≥ 139 mmHg and/or a diastolic blood pressure ≥ 90 mmHg using an average of 3 measurements, on 2 separate occasions - screening and baseline visits)
- Ability to provide informed consent
Who cannot join
- Systolic blood pressure < 120 or ≥ 139 mm Hg and/or diastolic blood pressure ≥ 90 mmHg
- Taking > 1 antihypertensive medication and/or taking the antihypertensive medication for < 3 months
- Diagnosed cancer, cardiovascular disease, diabetes, or gastrointestinal, kidney, liver, and/or pancreatic disease
- Triglycerides > 350 mg/dL, low-density lipoprotein cholesterol (LDL-C) ≥ 190 mg/dL, and/or taking a lipid-lowering medication
- Hormone replacement therapy use 6 months prior to study start
- Taking phosphodiesterase-5 inhibitors
Show all 12Show fewer
- Weight change ≥ 3 kg in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study
- Current smokers or history of smoking in the past 12 months
- Binge and/or heavy drinker (>3 drinks on any given occasion and/or >7 drinks/week for women, and >4 drinks on any given occasion and/or >14 drinks/week for men)
- Body mass index < 18.5 or > 40 kg/m2
- Active infection or antibiotic therapy
- Allergies or contraindication to study treatments, pharmacological agents, or procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado, 80523-1571
About this study
Official title: Blueberry Consumption for Improving Vascular Endothelial Dysfunction in Postmenopausal Women With Elevated Blood Pressure and Stage 1-Hypertension
Postmenopausal women are at an increased risk of developing cardiovascular disease (CVD) largely due to accelerated aging-related modifications to vascular health following menopause. The vascular endothelium is responsible for producing chemicals that are essential for proper vasodilation and blood flow and therefore is involved in maintaining normal blood pressure. A major modification that occurs during aging and is accelerated during menopause is termed vascular endothelial dysfunction which is characterized by impaired endothelium-dependent dilation. This can lead to increased blood pressure, atherosclerosis, and increased risk of CVD and death. Nitric oxide (NO) is a chemical produced by the endothelium and is essential for normal endothelial function and cardiovascular health. Vascular endothelial dysfunction is primarily caused by reduced NO bioavailability secondary to excessive oxidative stress. Approximately 3/4 of postmenopausal women have elevated blood pressure or hypertension which further worsens endothelial function and increases CVD risk through increased oxidative stress and inflammation. Blueberries are rich in phytochemicals including anthocyanins, phenolic acids, and pterostilbene. These phytochemicals and their metabolites are known to attenuate oxidative stress and inflammation. The overall goal of the current study is to assess the efficacy of blueberries to improve vascular endothelial dysfunction in this high-risk population and to gain insight into underlying mechanisms. 58 postmenopausal women with elevated blood pressure and stage 1-HTN will be asked to consume 22 grams freeze-dried blueberry powder or placebo powder per day for 12 weeks. Vascular endothelial function will be assessed at baseline and 12 weeks. Measurements indicative of vascular nitric oxide production, oxidative stress, inflammation, cardiometabolic health, cognitive function, and blueberry phytochemical metabolism will be measured at baseline and 12 weeks. Blood pressure will be assessed at baseline and 4, 8, and 12 weeks.
- Being tested
- Blueberry Powder, Placebo Powder
- Keywords
- Blueberries, Polyphenols, Cardiovascular Disease, Atherosclerosis, Oxidative Stress, Inflammmation, Endothelium, Vasodilation, Blood Pressure, Menopause, Women's Health, Functional Food, Bioactive Compounds, Dietary Supplements, Aging
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Atherosclerosis, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry PowderDietary supplement
22 g/day freeze-dried blueberry powder for 12 weeks
Placebo PowderDietary supplement
22 g/day placebo powder for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Blueberry | Experimental | 22 g/day freeze-dried blueberry powder for 12 weeks Receives: Dietary Supplement: Blueberry Powder |
| Control | Placebo comparator | 22 g/day placebo powder for 12 weeks Receives: Dietary Supplement: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent dilation
Assessed as brachial artery flow-mediated dilation in a study subset of participants
Measured: Baseline to 12 Weeks
Blood pressure
Assessed using an automated blood pressure monitor (SphgmoCor)
Measured: Baseline to 12 weeks
Secondary outcomes (8)
Vascular oxidative stress
Change in brachial artery flow-mediated dilation following acute infusion of ascorbic acid (a dose known to scavenge superoxide) as an index of vascular oxidative stress in a study subset of participants
Measured: Baseline and 12 weeks
Endothelial cell nitric oxide production, oxidative stress, and inflammation
Protein expression markers will be measured by quantitative immunofluorescence in biopsied venous endothelial cells in a study subset of participants
Measured: Baseline and 12 weeks
Systemic markers of cardiometabolic health
Circulating markers of lipid and glucose metabolism, nitric oxide, and inflammation
Measured: Baseline and 12 weeks
Plasma blueberry polyphenol metabolites
Targeted analysis of plasma metabolites by GC-MS and LC-MS
Measured: Baseline and 12 weeks
Endothelium-independent dilation
Assessed as brachial artery diameter responses to sublingual nitroglycerin in a study subset of participants
Measured: Baseline to 12 weeks
Augmentation index
Arterial stiffness assessed as augmentation index using the SphygmoCor XCEL
Measured: Baseline to 12 weeks
Pulse wave velocity
Arterial stiffness assessed as carotid-femoral pulse wave velocity using the SphygmoCor XCEL
Measured: Baseline to 12 weeks
Gut microbiota
Determine the effects on stool sample microbial populations
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start2 Dec 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Principal investigator, Sarah Johnson, Colorado State University
- Investigators
- Sarah A. Johnson, PhD, RDN, Principal investigator, Department of Food Science and Human Nutrition, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370991
- Sponsor's protocol ID
- 1255927
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2017
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25578927Woolf EK, Terwoord JD, Litwin NS, Vazquez AR, Lee SY, Ghanem N, Michell KA, Smith BT, Grabos LE, Ketelhut NB, Bachman NP, Smith ME, Le Sayec M, Rao S, Gentile CL, Weir TL, Rodriguez-Mateos A, Seals DR, Dinenno FA, Johnson SA. Daily blueberry consumption for 12 weeks improves endothelial function in postmenopausal women with above-normal blood pressure through reductions in oxidative stress: a randomized controlled trial. Food Funct. 2023 Mar 20;14(6):2621-2641. doi: 10.1039/d3fo00157a.
PubMed 36847333
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blueberry Consumption for Improving Vascular Endothelial Dysfunction in Postmenopausal Women With Elevated Blood Pressure and Stage 1-Hypertension
- ClinicalTrials.gov ID
- NCT03370991
- Acronym / sponsor ID
- 1255927
- Keywords
- Blueberries, Polyphenols, Cardiovascular Disease, Atherosclerosis, Oxidative Stress, Inflammmation, Endothelium, Vasodilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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.
Postmenopausal women are at an increased risk of developing cardiovascular disease (CVD) largely due to accelerated aging-related modifications to vascular health following menopause. The vascular endothelium is responsible for producing chemicals that are essential for proper vasodilation and blood flow and therefore is involved in maintaining normal blood pressure. A major modification that occurs during aging and is accelerated during menopause is termed vascular endothelial dysfunction which is characterized by impaired endothelium-dependent dilation. This can lead to increased blood pressure, atherosclerosis, and increased risk of CVD and death. Nitric oxide (NO) is a chemical produced by the endothelium and is essential for normal endothelial function and cardiovascular health. Vascular endothelial dysfunction is primarily caused by reduced NO bioavailability secondary to excessive oxidative stress. Approximately 3/4 of postmenopausal women have elevated blood pressure or hypertension which further worsens endothelial function and increases CVD risk through increased oxidative stress and inflammation. Blueberries are rich in phytochemicals including anthocyanins, phenolic acids, and pterostilbene. These phytochemicals and their metabolites are known to attenuate oxidative stress and inflammation. The overall goal of the current study is to assess the efficacy of blueberries to improve vascular endothelial dysfunction in this high-risk population and to gain insight into underlying mechanisms. 58 postmenopausal women with elevated blood pressure and stage 1-HTN will be asked to consume 22 grams freeze-dried blueberry powder or placebo powder per day for 12 weeks. Vascular endothelial function will be assessed at baseline and 12 weeks. Measurements indicative of vascular nitric oxide production, oxidative stress, inflammation, cardiometabolic health, cognitive function, and blueberry phytochemical metabolism will be measured at baseline and 12 weeks. Blood pressure will be assessed at baseline and 4, 8, and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry | Experimental | Dietary Supplement: Blueberry Powder22 g/day freeze-dried blueberry powder for 12 weeks |
| Control | Placebo comparator | Dietary Supplement: Placebo Powder22 g/day placebo powder for 12 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)
- Aged 45-65 years
- Postmenopausal women (≥ 1 years postmenopausal; natural or surgical menopause; confirmed by measurement of estradiol at a level < 30 pg/mL and follicle-stimulating hormone at a level ≥ 30 mIU/mL)
- Elevated or stage 1-HTN (confirmed as resting seated systolic blood pressure < 120 or ≥ 139 mmHg and/or a diastolic blood pressure ≥ 90 mmHg using an average of 3 measurements, on 2 separate occasions - screening and baseline visits)
- Ability to provide informed consent
Key exclusion criteria (12 listed)
- Systolic blood pressure < 120 or ≥ 139 mm Hg and/or diastolic blood pressure ≥ 90 mmHg
- Taking > 1 antihypertensive medication and/or taking the antihypertensive medication for < 3 months
- Diagnosed cancer, cardiovascular disease, diabetes, or gastrointestinal, kidney, liver, and/or pancreatic disease
- Triglycerides > 350 mg/dL, low-density lipoprotein cholesterol (LDL-C) ≥ 190 mg/dL, and/or taking a lipid-lowering medication
- Hormone replacement therapy use 6 months prior to study start
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 |
|---|---|---|
| Blueberry Powder22 g/day freeze-dried blueberry powder for 12 weeks | Dietary supplement | Blueberry |
| Placebo Powder22 g/day placebo powder for 12 weeks | Dietary supplement | Control |
Primary outcome
Endothelium-dependent dilation
Time frame: Baseline to 12 Weeks
Assessed as brachial artery flow-mediated dilation in a study subset of participants
Blood pressure
Time frame: Baseline to 12 weeks
Assessed using an automated blood pressure monitor (SphgmoCor)
8 secondary outcomes
Vascular oxidative stress
Time frame: Baseline and 12 weeks
Endothelial cell nitric oxide production, oxidative stress, and inflammation
Time frame: Baseline and 12 weeks
Systemic markers of cardiometabolic health
Time frame: Baseline and 12 weeks
Plasma blueberry polyphenol metabolites
Time frame: Baseline and 12 weeks
Endothelium-independent dilation
Time frame: Baseline to 12 weeks
Augmentation index
Time frame: Baseline to 12 weeks
Pulse wave velocity
Time frame: Baseline to 12 weeks
Gut microbiota
Time frame: Baseline to 12 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 14 Sep 2022.
- Background: 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.
- Derived from this study: PubMed 36847333Woolf EK, Terwoord JD, Litwin NS, Vazquez AR, Lee SY, Ghanem N, Michell KA, Smith BT, Grabos LE, Ketelhut NB, Bachman NP, Smith ME, Le Sayec M, Rao S, Gentile CL, Weir TL, Rodriguez-Mateos A, Seals DR, Dinenno FA, Johnson SA. Daily blueberry consumption for 12 weeks improves endothelial function in postmenopausal women with above-normal blood pressure through reductions in oxidative stress: a randomized controlled trial. Food Funct. 2023 Mar 20;14(6):2621-2641. doi: 10.1039/d3fo00157a.
- Related InfoLink provided by the sponsor.
- 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.
Sarah A. Johnson, PhD, RDN principal investigator
Department of Food Science and Human Nutrition, Colorado 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 Blueberry Powder in people with Menopause and Elevated Blood Pressure, run by Colorado 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 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 Sep 2022. 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?
Endothelium-dependent dilation (time frame: Baseline to 12 Weeks). The study lists 2 primary outcomes in all. 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 NCT03370991, which also lists 2 linked publications.
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 Sep 2022.