Effects of Blueberries in Older Adults (BnD)

• ClinicalTrials.gov Identifier: NCT05358210
• Recruitment Status: Recruiting
• First Posted: May 3, 2022
• Last Update Posted: December 16, 2022
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: U.S. Highbush Blueberry Council
• Information provided by (Responsible Party): Kenneth Mukamal, Beth Israel Deaconess Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Blood Pressure; Orthostatic Hypotension; Vascular Diseases	Behavioral: Blueberry Consumption; Behavioral: Dried Date Consumption	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Individual, 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: April 20, 2022
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Number of Self-Reported Falls [ 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.
2. Grip Strength [ Time Frame: 12 weeks after randomization ]
   Bilateral grip strength measured by a dynamometer
3. Sleep [ 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.
4. Incontinence [ 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.
5. Cardiac Ectopy [ Time Frame: 12 weeks after randomization ]
   Number of participants with atrial premature beats detected by a 24-hour Holter monitor
6. Troponin T (HS) [ Time Frame: 12 weeks after randomization ]
   Measured in blood sample
7. High Density Lipoprotein Cholesterol [ Time Frame: 12 weeks after randomization ]
   Measured in fasted blood as part of a lipid panel
8. Total Cholesterol [ Time Frame: 12 weeks after randomization ]
   Measured in fasted blood as part of a lipid panel
9. Derived Low Density Lipoprotein Cholesterol [ Time Frame: 12 weeks after randomization ]
   Measured in fasted blood as part of a lipid panel
10. Triglycerides [ Time Frame: 12 weeks after randomization ]
    Measured in fasted blood as part of a lipid panel
11. Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 12 weeks after randomization ]
    Measured in blood as part of basic metabolic panel
12. Albumin-to-Creatinine Ratio [ Time Frame: 12 weeks after randomization ]
    Measured in a spot urine sample to detect albuminuria
13. Fructosamine [ Time Frame: 12 weeks after randomization ]
    Measured in blood to estimate glucose levels over the previous 2-3 weeks.
14. Free Fatty Acids [ Time Frame: 12 weeks after randomization ]
    Measured in blood samples
15. C-Reactive Protein (CRP) [ Time Frame: 12 weeks after randomization ]
    Measured concentration in blood in response to inflammation
16. C-terminal telopeptide of type 1 collagen [ Time Frame: 12 weeks after randomization ]
    Measured in blood samples to assess bone turnover
17. T-Cell Receptor Portfolio [ Time Frame: 12 weeks after randomization ]
    Adaptive Immune Receptor Repertoire sequences in blood samples
18. Immune System Diversity [ Time Frame: 12 weeks after randomization ]
    Measure in blood samples to show diversity of immune sequences

Other Outcome Measures:

1. Liver Enzymes [ Time Frame: 12 weeks after randomization ]
   Measuring AST and ALT in blood samples
2. Total and Direct Bilirubin [ Time Frame: 12 weeks after randomization ]
   Measured in blood samples
3. Fasting Glucose [ Time Frame: 12 weeks after randomization ]
   Measured in blood samples
4. Fasting Insulin [ Time Frame: 12 weeks after randomization ]
   Measured in blood samples
5. White Blood Cell Count [ Time Frame: 12 weeks after randomization ]
   Measured in blood samples as part of complete blood count

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Kenneth J Mukamal, MD, MPH; 617-754-1401; kmukamal@bidmc.harvard.edu

Contact: Reva L Seager, MSPH, RDN; 617-754-1437; rseager@bidmc.harvard.edu

Locations

United States, Massachusetts

Center Communities of Brookline (CCB); Recruiting

Brookline, Massachusetts, United States, 02446

Contact: Reva Seager, MSPH, RDN 617-863-2352 rseager@bidmc.harvard.edu

Contact: Kenneth Mukamal, MD, MPH kmukamal@bidmc.harvard.edu

Sub-Investigator: Shivani Sahni, PhD

NewBridge on the Charles; Active, not recruiting

Dedham, Massachusetts, United States, 02026

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

U.S. Highbush Blueberry Council

Investigators

• Principal Investigator: Kenneth J Mukamal, MD, MPH; Beth Israel Deaconess Medical Center

  Study Documents (Full-Text)

Documents provided by Kenneth Mukamal, Beth Israel Deaconess Medical Center:

Study Protocol  [PDF] March 17, 2022

More Information

• Responsible Party: Kenneth Mukamal, Associate Section Chief for Research, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT05358210
• Other Study ID Numbers: 2021P001034
• First Posted: May 3, 2022
• Last Update Posted: December 16, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kenneth Mukamal, Beth Israel Deaconess Medical Center:

Blueberries; Dates; Older Adults; Blood pressure; Fruit; Vascular health; Dietitian

Additional relevant MeSH terms:

Hypotension, Orthostatic; Hypotension; Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases