NCT Number: NCT05358210
This randomized, parallel-design trial will evaluate specific clinical and physiological effects of whole blueberries in adults 70 years of age or older.
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Notify Me70 year–100 year
All sexes
Interventional
Not applicable
Center Communities of Brookline (CCB), Brookline, Massachusetts, United States
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:
or
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 weeks after randomization
24-hour wake-time ambulatory blood pressure monitoring
Time frame: 12-weeks after randomization
Supine and standing blood pressure
Time frame: 12 weeks after randomization
Short Physical Performance Battery
Time frame: 12 weeks after randomization
Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory
Time frame: 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.
Time frame: 12 weeks after randomization
Bilateral grip strength measured by a dynamometer
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks after randomization
Number of participants with atrial premature beats detected by a 24-hour Holter monitor
Time frame: 12 weeks after randomization
Measured in blood sample
Time frame: 12 weeks after randomization
Measured in fasted blood as part of a lipid panel
Time frame: 12 weeks after randomization
Measured in fasted blood as part of a lipid panel
Time frame: 12 weeks after randomization
Measured in fasted blood as part of a lipid panel
Time frame: 12 weeks after randomization
Measured in fasted blood as part of a lipid panel
Time frame: 12 weeks after randomization
Measured in blood as part of basic metabolic panel
Time frame: 12 weeks after randomization
Measured in a spot urine sample to detect albuminuria
Time frame: 12 weeks after randomization
Measured in blood to estimate glucose levels over the previous 2-3 weeks.
Time frame: 12 weeks after randomization
Measured in blood samples
Time frame: 12 weeks after randomization
Measured concentration in blood in response to inflammation
Time frame: 12 weeks after randomization
Measured in blood samples to assess bone turnover
Time frame: 12 weeks after randomization
Adaptive Immune Receptor Repertoire sequences in blood samples
Time frame: 12 weeks after randomization
Measure in blood samples to show diversity of immune sequences
Time frame: 12 weeks after randomization
Measuring AST and ALT in blood samples
Time frame: 12 weeks after randomization
Measured in blood samples
Time frame: 12 weeks after randomization
Measured in blood samples
Time frame: 12 weeks after randomization
Measured in blood samples
Time frame: 12 weeks after randomization
Measured in blood samples as part of complete blood count
Beth Israel Deaconess Medical Center
Other
The Clinical and Physiological Effects of Blueberry Consumption in Older Adults
Acronym: BnD
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