Effects of Blueberries in Older Adults (BnD)

Beth Israel Lahey Health

Status: Completed

Conditions: Vascular Diseases; Orthostatic Hypotension; Blood Pressure

Treatments: Behavioral: Dried Date Consumption; Behavioral: Blueberry Consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT05358210

2021P001034

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 70 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Blueberry Consumption

Experimental group

Description:

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

Treatment:

Behavioral: Blueberry Consumption

Dried Date Consumption

Active Comparator group

Description:

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

Treatment:

Behavioral: Dried Date Consumption