Effects of Blueberries in Older Adults

Not Applicable

Completed

• Conditions: Orthostatic Hypotension; Vascular Diseases; Blood Pressure

• Registration Number: NCT05358210
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Center Communities of Brookline (CCB); 🇺🇸 Brookline, Massachusetts, United States

NewBridge on the Charles; 🇺🇸 Dedham, Massachusetts, United States