Effects of Blueberries in Older Adults
- Conditions
- Orthostatic HypotensionVascular DiseasesBlood Pressure
- Interventions
- Behavioral: Blueberry ConsumptionBehavioral: Dried Date Consumption
- Registration Number
- NCT05358210
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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. 1 cup of frozen blueberries daily for 12 weeks
or
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 70 years old
- Independent-living
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blueberry Consumption Blueberry Consumption Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks. Dried Date Consumption Dried Date Consumption Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Ambulatory Blood Pressure Monitoring 12 weeks after randomization 24-hour wake-time ambulatory blood pressure monitoring
Lower Extremity Functioning 12 weeks after randomization Short Physical Performance Battery
Cognition 12 weeks after randomization Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory
Orthostatic Hypotension 12-weeks after randomization Supine and standing blood pressure
- Secondary Outcome Measures
Name Time Method Number of Self-Reported Falls Weekly for 12 weeks between baseline and follow-up 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.
Total Cholesterol 12 weeks after randomization Measured in fasted blood as part of a lipid panel
Free Fatty Acids 12 weeks after randomization Measured in blood samples
Sleep 12 weeks after randomization 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.
Troponin T (HS) 12 weeks after randomization Measured in blood sample
Derived Low Density Lipoprotein Cholesterol 12 weeks after randomization Measured in fasted blood as part of a lipid panel
Triglycerides 12 weeks after randomization Measured in fasted blood as part of a lipid panel
Grip Strength 12 weeks after randomization Bilateral grip strength measured by a dynamometer
Estimated Glomerular Filtration Rate (eGFR) 12 weeks after randomization Measured in blood as part of basic metabolic panel
C-Reactive Protein (CRP) 12 weeks after randomization Measured concentration in blood in response to inflammation
Incontinence 12 weeks after randomization 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 12 weeks after randomization Number of participants with atrial premature beats detected by a 24-hour Holter monitor
High Density Lipoprotein Cholesterol 12 weeks after randomization Measured in fasted blood as part of a lipid panel
Albumin-to-Creatinine Ratio 12 weeks after randomization Measured in a spot urine sample to detect albuminuria
C-terminal telopeptide of type 1 collagen 12 weeks after randomization Measured in blood samples to assess bone turnover
Fructosamine 12 weeks after randomization Measured in blood to estimate glucose levels over the previous 2-3 weeks.
T-Cell Receptor Portfolio 12 weeks after randomization Adaptive Immune Receptor Repertoire sequences in blood samples
Immune System Diversity 12 weeks after randomization Measure in blood samples to show diversity of immune sequences
Trial Locations
- Locations (2)
Center Communities of Brookline (CCB)
đŸ‡ºđŸ‡¸Brookline, Massachusetts, United States
NewBridge on the Charles
đŸ‡ºđŸ‡¸Dedham, Massachusetts, United States