Effects of Blueberries in Older Adults

Study Overview
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Brief Summary
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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
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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 cup of frozen blueberries daily for 12 weeks or 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.

Official Title
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The Clinical and Physiological Effects of Blueberry Consumption in Older Adults

Conditions
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Blood Pressure, Orthostatic Hypotension, Vascular Diseases

Intervention / Treatment
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* Behavioral: Blueberry Consumption
* Behavioral: Dried Date Consumption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individual, parallel-design, randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blueberry Consumption<br>Randomized participants will consume 1 cup of frozen blueberries, provided by the trial, daily for 12 weeks. | Behavioral: Blueberry Consumption<br>* 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.<br>|
| Active Comparator: Dried Date Consumption<br>Randomized participants will consume 2-3 dried dates, provided by the trial, daily for 12 weeks. | Behavioral: Dried Date Consumption<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blueberries, Dates, Older Adults, Blood pressure, Fruit, Vascular health, Dietitian