Clinical trial NCT05358210: Effects of Blueberries in Older Adults
Official title: The Clinical and Physiological Effects of Blueberry Consumption in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Orthostatic Hypotension
Vascular Diseases
Keywords: Blueberries
Dates
Older Adults
Blood pressure
Fruit
Vascular health
Dietitian
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: U.S. Highbush Blueberry Council
First posted: 2022-05-03
Enrollment: 61
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual, parallel-design, randomized trial
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Ambulatory Blood Pressure Monitoring
timeFrame: 12 weeks after randomization
measure: Orthostatic Hypotension
timeFrame: 12-weeks after randomization
measure: Lower Extremity Functioning
timeFrame: 12 weeks after randomization
measure: Cognition
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: Number of Self-Reported Falls
timeFrame: Weekly for 12 weeks between baseline and follow-up
measure: Grip Strength
timeFrame: 12 weeks after randomization
measure: Sleep
timeFrame: 12 weeks after randomization
measure: Incontinence
timeFrame: 12 weeks after randomization
measure: Cardiac Ectopy
timeFrame: 12 weeks after randomization
measure: Troponin T (HS)
timeFrame: 12 weeks after randomization
measure: High Density Lipoprotein Cholesterol
timeFrame: 12 weeks after randomization
measure: Total Cholesterol
timeFrame: 12 weeks after randomization
measure: Derived Low Density Lipoprotein Cholesterol
timeFrame: 12 weeks after randomization
measure: Triglycerides
timeFrame: 12 weeks after randomization
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 12 weeks after randomization
measure: Albumin-to-Creatinine Ratio
timeFrame: 12 weeks after randomization
measure: Fructosamine
timeFrame: 12 weeks after randomization
measure: Free Fatty Acids
timeFrame: 12 weeks after randomization
measure: C-Reactive Protein (CRP)
timeFrame: 12 weeks after randomization
measure: C-terminal telopeptide of type 1 collagen
timeFrame: 12 weeks after randomization
measure: T-Cell Receptor Portfolio
timeFrame: 12 weeks after randomization
measure: Immune System Diversity
timeFrame: 12 weeks after randomization
Other outcomes:
measure: Liver Enzymes
timeFrame: 12 weeks after randomization
measure: Total and Direct Bilirubin
timeFrame: 12 weeks after randomization
measure: Fasting Glucose
timeFrame: 12 weeks after randomization
measure: Fasting Insulin
timeFrame: 12 weeks after randomization
measure: White Blood Cell Count
timeFrame: 12 weeks after randomization
Locations:
city: Brookline
country: United States
facility: Center Communities of Brookline (CCB)
state: Massachusetts
city: Dedham
country: United States
facility: NewBridge on the Charles
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Kenneth J Mukamal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: