Effects of Blueberries in Older Adults (BnD)
Primary Purpose
Blood Pressure, Orthostatic Hypotension, Vascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry Consumption
Dried Date Consumption
Sponsored by
About this trial
This is an interventional prevention trial for Blood Pressure focused on measuring Blueberries, Dates, Older Adults, Blood pressure, Fruit, Vascular health, Dietitian
Eligibility Criteria
Inclusion Criteria:
- 70 years old
- Independent-living
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Center Communities of Brookline (CCB)Recruiting
- NewBridge on the Charles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Blueberry Consumption
Dried Date Consumption
Arm Description
Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks.
Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks.
Outcomes
Primary Outcome Measures
Ambulatory Blood Pressure Monitoring
24-hour wake-time ambulatory blood pressure monitoring
Orthostatic Hypotension
Supine and standing blood pressure
Lower Extremity Functioning
Short Physical Performance Battery
Cognition
Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory
Secondary Outcome Measures
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.
Grip Strength
Bilateral grip strength measured by a dynamometer
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.
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.
Cardiac Ectopy
Number of participants with atrial premature beats detected by a 24-hour Holter monitor
Troponin T (HS)
Measured in blood sample
High Density Lipoprotein Cholesterol
Measured in fasted blood as part of a lipid panel
Total Cholesterol
Measured in fasted blood as part of a lipid panel
Derived Low Density Lipoprotein Cholesterol
Measured in fasted blood as part of a lipid panel
Triglycerides
Measured in fasted blood as part of a lipid panel
Estimated Glomerular Filtration Rate (eGFR)
Measured in blood as part of basic metabolic panel
Albumin-to-Creatinine Ratio
Measured in a spot urine sample to detect albuminuria
Fructosamine
Measured in blood to estimate glucose levels over the previous 2-3 weeks.
Free Fatty Acids
Measured in blood samples
C-Reactive Protein (CRP)
Measured concentration in blood in response to inflammation
C-terminal telopeptide of type 1 collagen
Measured in blood samples to assess bone turnover
T-Cell Receptor Portfolio
Adaptive Immune Receptor Repertoire sequences in blood samples
Immune System Diversity
Measure in blood samples to show diversity of immune sequences
Full Information
NCT ID
NCT05358210
First Posted
April 21, 2022
Last Updated
August 10, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
U.S. Highbush Blueberry Council
1. Study Identification
Unique Protocol Identification Number
NCT05358210
Brief Title
Effects of Blueberries in Older Adults
Acronym
BnD
Official Title
The Clinical and Physiological Effects of Blueberry Consumption in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
U.S. Highbush Blueberry Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Orthostatic Hypotension, Vascular Diseases
Keywords
Blueberries, Dates, Older Adults, Blood pressure, Fruit, Vascular health, Dietitian
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individual, parallel-design, randomized trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blueberry Consumption
Arm Type
Experimental
Arm Description
Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks.
Arm Title
Dried Date Consumption
Arm Type
Active Comparator
Arm Description
Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Blueberry Consumption
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dried Date Consumption
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ambulatory Blood Pressure Monitoring
Description
24-hour wake-time ambulatory blood pressure monitoring
Time Frame
12 weeks after randomization
Title
Orthostatic Hypotension
Description
Supine and standing blood pressure
Time Frame
12-weeks after randomization
Title
Lower Extremity Functioning
Description
Short Physical Performance Battery
Time Frame
12 weeks after randomization
Title
Cognition
Description
Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory
Time Frame
12 weeks after randomization
Secondary Outcome Measure Information:
Title
Number of Self-Reported Falls
Description
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.
Time Frame
Weekly for 12 weeks between baseline and follow-up
Title
Grip Strength
Description
Bilateral grip strength measured by a dynamometer
Time Frame
12 weeks after randomization
Title
Sleep
Description
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.
Time Frame
12 weeks after randomization
Title
Incontinence
Description
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.
Time Frame
12 weeks after randomization
Title
Cardiac Ectopy
Description
Number of participants with atrial premature beats detected by a 24-hour Holter monitor
Time Frame
12 weeks after randomization
Title
Troponin T (HS)
Description
Measured in blood sample
Time Frame
12 weeks after randomization
Title
High Density Lipoprotein Cholesterol
Description
Measured in fasted blood as part of a lipid panel
Time Frame
12 weeks after randomization
Title
Total Cholesterol
Description
Measured in fasted blood as part of a lipid panel
Time Frame
12 weeks after randomization
Title
Derived Low Density Lipoprotein Cholesterol
Description
Measured in fasted blood as part of a lipid panel
Time Frame
12 weeks after randomization
Title
Triglycerides
Description
Measured in fasted blood as part of a lipid panel
Time Frame
12 weeks after randomization
Title
Estimated Glomerular Filtration Rate (eGFR)
Description
Measured in blood as part of basic metabolic panel
Time Frame
12 weeks after randomization
Title
Albumin-to-Creatinine Ratio
Description
Measured in a spot urine sample to detect albuminuria
Time Frame
12 weeks after randomization
Title
Fructosamine
Description
Measured in blood to estimate glucose levels over the previous 2-3 weeks.
Time Frame
12 weeks after randomization
Title
Free Fatty Acids
Description
Measured in blood samples
Time Frame
12 weeks after randomization
Title
C-Reactive Protein (CRP)
Description
Measured concentration in blood in response to inflammation
Time Frame
12 weeks after randomization
Title
C-terminal telopeptide of type 1 collagen
Description
Measured in blood samples to assess bone turnover
Time Frame
12 weeks after randomization
Title
T-Cell Receptor Portfolio
Description
Adaptive Immune Receptor Repertoire sequences in blood samples
Time Frame
12 weeks after randomization
Title
Immune System Diversity
Description
Measure in blood samples to show diversity of immune sequences
Time Frame
12 weeks after randomization
Other Pre-specified Outcome Measures:
Title
Liver Enzymes
Description
Measuring AST and ALT in blood samples
Time Frame
12 weeks after randomization
Title
Total and Direct Bilirubin
Description
Measured in blood samples
Time Frame
12 weeks after randomization
Title
Fasting Glucose
Description
Measured in blood samples
Time Frame
12 weeks after randomization
Title
Fasting Insulin
Description
Measured in blood samples
Time Frame
12 weeks after randomization
Title
White Blood Cell Count
Description
Measured in blood samples as part of complete blood count
Time Frame
12 weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
70 years old
Independent-living
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth J Mukamal, MD, MPH
Phone
617-754-1401
Email
kmukamal@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Reva L Seager, MSPH, RDN
Phone
617-754-1437
Email
rseager@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth J Mukamal, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center Communities of Brookline (CCB)
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reva Seager, MSPH, RDN
Phone
617-863-2352
Email
rseager@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kenneth Mukamal, MD, MPH
Email
kmukamal@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Shivani Sahni, PhD
Facility Name
NewBridge on the Charles
City
Dedham
State/Province
Massachusetts
ZIP/Postal Code
02026
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Blueberries in Older Adults
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