The Clinical and Physiological Effects of Blueberry Consumption in Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Ambulatory Blood Pressure Monitoring
Study Overview
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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to 100 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Blueberry Consumption
Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks.
Intervention: Blueberry Consumption (Behavioral)
Dried Date Consumption
Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks.
Intervention: Dried Date Consumption (Behavioral)
Outcomes
Primary Outcomes
Ambulatory Blood Pressure Monitoring
Time Frame: 12 weeks after randomization
24-hour wake-time ambulatory blood pressure monitoring
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
Orthostatic Hypotension
Time Frame: 12-weeks after randomization
Supine and standing blood pressure
Secondary Outcomes
- Troponin T (HS)(12 weeks after randomization)
- C-Reactive Protein (CRP)(12 weeks after randomization)
- Number of Self-Reported Falls(Weekly for 12 weeks between baseline and follow-up)
- Total Cholesterol(12 weeks after randomization)
- Free Fatty Acids(12 weeks after randomization)
- Sleep(12 weeks after randomization)
- Derived Low Density Lipoprotein Cholesterol(12 weeks after randomization)
- Triglycerides(12 weeks after randomization)
- Grip Strength(12 weeks after randomization)
- Estimated Glomerular Filtration Rate (eGFR)(12 weeks after randomization)
- Incontinence(12 weeks after randomization)
- Cardiac Ectopy(12 weeks after randomization)
- High Density Lipoprotein Cholesterol(12 weeks after randomization)
- Albumin-to-Creatinine Ratio(12 weeks after randomization)
- C-terminal telopeptide of type 1 collagen(12 weeks after randomization)
- Fructosamine(12 weeks after randomization)
- T-Cell Receptor Portfolio(12 weeks after randomization)
- Immune System Diversity(12 weeks after randomization)
Investigators
Kenneth Mukamal
Associate Section Chief for Research
Beth Israel Deaconess Medical Center