Blood PressureBnDNCT05358210
Effects of Blueberries in Older Adults
A study testing Blueberry Consumption and Dried Date Consumption in people with Blood Pressure and Orthostatic Hypotension, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
This randomized, parallel-design trial will evaluate specific clinical and physiological effects of whole blueberries in adults 70 years of age or older. Read more about this study
- Who is it for?
- Ages 70 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Orthostatic Hypotension, Vascular Diseases
- What is being tested?
- Blueberry Consumption and Dried Date Consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2022to 22 May 2024
- 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 70 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 years old
- Independent-living
Who cannot join
- Cardiovascular event or procedure within 3 months of randomization
- AHA Class III-IV heart failure
- Intolerance or allergy to blueberries or dates
- History of gastric bypass surgery
- Any planned hospitalization or vacation in the ensuing 4 months
- Any current cancer treatment
Show all 12Show fewer
- End-stage renal disease
- Any organ transplant
- Uncontrolled diabetes mellitus with hemoglobin A1c >9%
- Systolic blood pressure >200 mmHg
- Inability to provide personal informed consent (e.g. cognitive impairment)
- Investigator concern
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center Communities of Brookline (CCB)
Brookline, Massachusetts, 02446
NewBridge on the Charles
Dedham, Massachusetts, 02026
About this study
Official title: The Clinical and Physiological Effects of Blueberry Consumption in Older Adults
This randomized, parallel-design trial will evaluate specific clinical and physiological effects of whole blueberries in adults 70 years of age or older.
Read the detailed description
Although much is already known about the benefits of a healthy diet for the prevention of a wide range of chronic diseases, including the particular health benefits of anthocyanin-rich foods, these effects have been examined with much less frequency in older adults, who tend to be excluded from formal feeding studies and, until recently, have represented a small proportion of ongoing cohort studies. The proposed study will randomize approximately 46 women and 24 men, representative of the proportion of elderly women and men in the U.S. to consume either:
- 1 cup of frozen blueberries daily for 12 weeks or
- 2-3 dried dates daily for 12 weeks.
Dates were chosen as a control food because they contain negligible polyphenols, proportionately high caloric content, and a convenient form for storage. After the 12-week intervention, researchers will repeat in-person study assessments from baseline.
- Conditions
- Blood Pressure, Orthostatic Hypotension, Vascular Diseases
- Being tested
- Blueberry Consumption, Dried Date Consumption
- Keywords
- Blueberries, Dates, Older Adults, Blood pressure, Fruit, Vascular health, Dietitian
- Medical subject headings
- Hypotension, Orthostatic, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry ConsumptionBehavioural
Participants will consume 1 cup of frozen blueberries daily for the 12 weeks of the intervention. The study dietitian will provide educational materials and monitor compliance through weekly check-ins. Participants will be instructed to avoid all other high-anthocyanin foods including other berries, cherries, currants, cabbage, red wine, and eggplant.
Dried Date ConsumptionBehavioural
Participants will consume 2-3 dried dates daily for the 12 weeks of the intervention, an isocaloric portion of fruit compared to the blueberry group. The study dietitian will provide educational materials and monitor compliance through weekly check-ins. Participants will be instructed to avoid all other high-anthocyanin foods including blueberries, other berries, cherries, currants, cabbage, red wine, and eggplant.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Consumption | Experimental | Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks. Receives: Behavioral: Blueberry Consumption |
| Dried Date Consumption | Active comparator | Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks. Receives: Behavioral: Dried Date Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure Monitoring
24-hour wake-time ambulatory blood pressure monitoring
Measured: 12 weeks after randomization
Orthostatic Hypotension
Supine and standing blood pressure
Measured: 12-weeks after randomization
Lower Extremity Functioning
Short Physical Performance Battery
Measured: 12 weeks after randomization
Cognition
Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory
Measured: 12 weeks after randomization
Secondary outcomes (18)
Number of Self-Reported Falls
Investigators will administer the Fall Follow-Up Questionnaire from the Study to Understand Fall Reduction and Vitamin D in You (STURDY) to participants that self-report falls to record details on each fall.
Measured: Weekly for 12 weeks between baseline and follow-up
Grip Strength
Bilateral grip strength measured by a dynamometer
Measured: 12 weeks after randomization
Sleep
Pittsburgh Sleep Quality Index. The 19 self-rated items are combined to form 7 "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The 7 component scores are then added to yield one "global score", with a range of 0-21 points, "0" indicating no difficulty and "21" indicated severe difficulties in all sleep areas.
Measured: 12 weeks after randomization
Incontinence
Questionnaire for Urinary Incontinence Diagnosis. The first 3 items focus on stress incontinence symptoms and the last 3 on urge incontinence symptoms. Each item includes 6 frequency-based response options, which are scored from 0 to 5 points. Scores are calculated in an additive fashion, resulting in separate Stress and Urge score, each ranging from 0-15 points. Higher scores indicate more severe incontinence symptoms.
Measured: 12 weeks after randomization
Cardiac Ectopy
Number of participants with atrial premature beats detected by a 24-hour Holter monitor
Measured: 12 weeks after randomization
Troponin T (HS)
Measured in blood sample
Measured: 12 weeks after randomization
High Density Lipoprotein Cholesterol
Measured in fasted blood as part of a lipid panel
Measured: 12 weeks after randomization
Total Cholesterol
Measured in fasted blood as part of a lipid panel
Measured: 12 weeks after randomization
Derived Low Density Lipoprotein Cholesterol
Measured in fasted blood as part of a lipid panel
Measured: 12 weeks after randomization
Triglycerides
Measured in fasted blood as part of a lipid panel
Measured: 12 weeks after randomization
Estimated Glomerular Filtration Rate (eGFR)
Measured in blood as part of basic metabolic panel
Measured: 12 weeks after randomization
Albumin-to-Creatinine Ratio
Measured in a spot urine sample to detect albuminuria
Measured: 12 weeks after randomization
Fructosamine
Measured in blood to estimate glucose levels over the previous 2-3 weeks.
Measured: 12 weeks after randomization
Free Fatty Acids
Measured in blood samples
Measured: 12 weeks after randomization
C-Reactive Protein (CRP)
Measured concentration in blood in response to inflammation
Measured: 12 weeks after randomization
C-terminal telopeptide of type 1 collagen
Measured in blood samples to assess bone turnover
Measured: 12 weeks after randomization
T-Cell Receptor Portfolio
Adaptive Immune Receptor Repertoire sequences in blood samples
Measured: 12 weeks after randomization
Immune System Diversity
Measure in blood samples to show diversity of immune sequences
Measured: 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start20 Apr 2022
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual, parallel-design, randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Principal investigator, Kenneth Mukamal, Beth Israel Deaconess Medical Center
- Investigators
- Kenneth J Mukamal, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358210
- Sponsor's protocol ID
- 2021P001034
- Acronym
- BnD
- Status last verified
- Jul 2024
- First submitted
- 21 Apr 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Physiological Effects of Blueberry Consumption in Older Adults
- ClinicalTrials.gov ID
- NCT05358210
- Acronym / sponsor ID
- BnD / 2021P001034
- Conditions
- Blood Pressure, Orthostatic Hypotension, Vascular Diseases
- Keywords
- Blueberries, Dates, Older Adults, Blood pressure, Fruit, Vascular health, Dietitian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 3 May 2022 (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.
This randomized, parallel-design trial will evaluate specific clinical and physiological effects of whole blueberries in adults 70 years of age or older.
Detailed description
Although much is already known about the benefits of a healthy diet for the prevention of a wide range of chronic diseases, including the particular health benefits of anthocyanin-rich foods, these effects have been examined with much less frequency in older adults, who tend to be excluded from formal feeding studies and, until recently, have represented a small proportion of ongoing cohort studies. The proposed study will randomize approximately 46 women and 24 men, representative of the proportion of elderly women and men in the U.S. to consume either:
- 1 cup of frozen blueberries daily for 12 weeks or
- 2-3 dried dates daily for 12 weeks.
Dates were chosen as a control food because they contain negligible polyphenols, proportionately high caloric content, and a convenient form for storage. After the 12-week intervention, researchers will repeat in-person study assessments from baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individual, parallel-design, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Blueberry Consumption | Experimental | Behavioral: Blueberry ConsumptionRandomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks. |
| Dried Date Consumption | Active comparator | Behavioral: Dried Date ConsumptionRandomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 70 years old
- Independent-living
Key exclusion criteria (12 listed)
- Cardiovascular event or procedure within 3 months of randomization
- AHA Class III-IV heart failure
- Intolerance or allergy to blueberries or dates
- History of gastric bypass surgery
- Any planned hospitalization or vacation in the ensuing 4 months
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 ConsumptionParticipants will consume 1 cup of frozen blueberries daily for the 12 weeks of the intervention. The study dietitian will provide educational materials and monitor compliance through weekly check-ins. Participants will be instructed to avoid all other high-anthocyanin foods including other berries, cherries, currants, cabbage, red wine, and eggplant. | Behavioural | Blueberry Consumption |
| Dried Date ConsumptionParticipants will consume 2-3 dried dates daily for the 12 weeks of the intervention, an isocaloric portion of fruit compared to the blueberry group. The study dietitian will provide educational materials and monitor compliance through weekly check-ins. Participants will be instructed to avoid all other high-anthocyanin foods including blueberries, other berries, cherries, currants, cabbage, red wine, and eggplant. | Behavioural | Dried Date Consumption |
Primary outcome
Ambulatory Blood Pressure Monitoring
Time frame: 12 weeks after randomization
24-hour wake-time ambulatory blood pressure monitoring
Orthostatic Hypotension
Time frame: 12-weeks after randomization
Supine and standing blood pressure
Lower Extremity Functioning
Time frame: 12 weeks after randomization
Short Physical Performance Battery
Cognition
Time frame: 12 weeks after randomization
Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory
18 secondary outcomes
Number of Self-Reported Falls
Time frame: Weekly for 12 weeks between baseline and follow-up
Grip Strength
Time frame: 12 weeks after randomization
Sleep
Time frame: 12 weeks after randomization
Incontinence
Time frame: 12 weeks after randomization
Cardiac Ectopy
Time frame: 12 weeks after randomization
Troponin T (HS)
Time frame: 12 weeks after randomization
High Density Lipoprotein Cholesterol
Time frame: 12 weeks after randomization
Total Cholesterol
Time frame: 12 weeks after randomization
Derived Low Density Lipoprotein Cholesterol
Time frame: 12 weeks after randomization
Triglycerides
Time frame: 12 weeks after randomization
Estimated Glomerular Filtration Rate (eGFR)
Time frame: 12 weeks after randomization
Albumin-to-Creatinine Ratio
Time frame: 12 weeks after randomization
Fructosamine
Time frame: 12 weeks after randomization
Free Fatty Acids
Time frame: 12 weeks after randomization
C-Reactive Protein (CRP)
Time frame: 12 weeks after randomization
C-terminal telopeptide of type 1 collagen
Time frame: 12 weeks after randomization
T-Cell Receptor Portfolio
Time frame: 12 weeks after randomization
Immune System Diversity
Time frame: 12 weeks after randomization
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 18 Jul 2024.
- 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.
Kenneth J Mukamal, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Consumption and Dried Date Consumption in people with Blood Pressure and Orthostatic Hypotension, run by Beth Israel Deaconess Medical Center at 2 sites 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 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Ambulatory Blood Pressure Monitoring (time frame: 12 weeks after randomization). The study lists 4 primary outcomes in all. 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 18 Jul 2024.