Effects of Blueberries in Older Adults (BnD)

The Clinical and Physiological Effects of Blueberry Consumption in Older Adults

This randomized, parallel-design trial will evaluate specific clinical and physiological effects of whole blueberries in adults 70 years of age or older.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Blood Pressure; Orthostatic Hypotension
• Intervention / Treatment: Behavioral: Blueberry Consumption; Behavioral: Dried Date Consumption

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brookline, Massachusetts, United States, 02446
      • Center Communities of Brookline (CCB)
    • Dedham, Massachusetts, United States, 02026
      • NewBridge on the Charles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory Blood Pressure Monitoring	24-hour wake-time ambulatory blood pressure monitoring	12 weeks after randomization
Orthostatic Hypotension	Supine and standing blood pressure	12-weeks after randomization
Lower Extremity Functioning	Short Physical Performance Battery	12 weeks after randomization
Cognition	Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory	12 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weekly for 12 weeks between baseline and follow-up
Grip Strength	Bilateral grip strength measured by a dynamometer	12 weeks after randomization
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.	12 weeks after randomization
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.	12 weeks after randomization
Cardiac Ectopy	Number of participants with atrial premature beats detected by a 24-hour Holter monitor	12 weeks after randomization
Troponin T (HS)	Measured in blood sample	12 weeks after randomization
High Density Lipoprotein Cholesterol	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Total Cholesterol	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Derived Low Density Lipoprotein Cholesterol	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Triglycerides	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Estimated Glomerular Filtration Rate (eGFR)	Measured in blood as part of basic metabolic panel	12 weeks after randomization
Albumin-to-Creatinine Ratio	Measured in a spot urine sample to detect albuminuria	12 weeks after randomization
Fructosamine	Measured in blood to estimate glucose levels over the previous 2-3 weeks.	12 weeks after randomization
Free Fatty Acids	Measured in blood samples	12 weeks after randomization
C-Reactive Protein (CRP)	Measured concentration in blood in response to inflammation	12 weeks after randomization
C-terminal telopeptide of type 1 collagen	Measured in blood samples to assess bone turnover	12 weeks after randomization
T-Cell Receptor Portfolio	Adaptive Immune Receptor Repertoire sequences in blood samples	12 weeks after randomization
Immune System Diversity	Measure in blood samples to show diversity of immune sequences	12 weeks after randomization

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: U.S. Highbush Blueberry Council
• Investigators: Principal Investigator: Kenneth J Mukamal, MD, MPH, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Older Adults; Blood pressure; Fruit; Dates; Blueberries; Vascular health; Dietitian
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Vascular Diseases; Hypotension; Hypotension, Orthostatic
• Other Study ID Numbers: 2021P001034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No