BnD: Effects of Blueberries in Older Adults

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05358210

Collaborator

U.S. Highbush Blueberry Council (Other)

Enrollment

Location

Arms

14.4

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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 at a congregate-living facility.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Orthostatic Hypotension Vascular Diseases	Behavioral: Blueberry Consumption Behavioral: Dried Date Consumption	N/A

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., living at Hebrew SeniorLife-affiliated retirement communities in Massachusetts to consume either:

1 cup of frozen blueberries daily for 12 weeks

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

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Individual, parallel-design, randomized trialIndividual, parallel-design, randomized trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Clinical and Physiological Effects of Blueberry Consumption in Older Adults

Actual Study Start Date :

Apr 20, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blueberry Consumption Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks.	Behavioral: Blueberry Consumption 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.
Active Comparator: Dried Date Consumption Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks.	Behavioral: Dried Date Consumption 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.

Arm

Intervention/Treatment

Experimental: Blueberry Consumption

Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks.

Behavioral: Blueberry Consumption

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.

Active Comparator: Dried Date Consumption

Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks.

Behavioral: Dried Date Consumption

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.

Outcome Measures

Primary Outcome Measures

Ambulatory Blood Pressure Monitoring [12 weeks after randomization]
24-hour wake-time ambulatory blood pressure monitoring
Orthostatic Hypotension [12-weeks after randomization]
Supine and standing blood pressure
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

Secondary Outcome Measures

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.
Grip Strength [12 weeks after randomization]
Bilateral grip strength measured by a dynamometer
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.
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
Troponin T (HS) [12 weeks after randomization]
Measured in blood sample
High Density Lipoprotein Cholesterol [12 weeks after randomization]
Measured in fasted blood as part of a lipid panel
Total Cholesterol [12 weeks after randomization]
Measured in fasted blood as part of a lipid panel
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
Estimated Glomerular Filtration Rate (eGFR) [12 weeks after randomization]
Measured in blood as part of basic metabolic panel
Albumin-to-Creatinine Ratio [12 weeks after randomization]
Measured in a spot urine sample to detect albuminuria
Fructosamine [12 weeks after randomization]
Measured in blood to estimate glucose levels over the previous 2-3 weeks.
Free Fatty Acids [12 weeks after randomization]
Measured in blood samples
C-Reactive Protein (CRP) [12 weeks after randomization]
Measured concentration in blood in response to inflammation
C-terminal telopeptide of type 1 collagen [12 weeks after randomization]
Measured in blood samples to assess bone turnover
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

Other Outcome Measures

Liver Enzymes [12 weeks after randomization]
Measuring AST and ALT in blood samples
Total and Direct Bilirubin [12 weeks after randomization]
Measured in blood samples
Fasting Glucose [12 weeks after randomization]
Measured in blood samples
Fasting Insulin [12 weeks after randomization]
Measured in blood samples
White Blood Cell Count [12 weeks after randomization]
Measured in blood samples as part of complete blood count