Effects of Blueberries in Older Adults

Blood Pressure Clinical Trial

— BnD  

Official title:

The Clinical and Physiological Effects of Blueberry Consumption in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358210
• Other study ID #: 2021P001034
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Kenneth J Mukamal, MD, MPH
• Phone: 617-754-1401
• Email: kmukamal[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Vascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center Communities of Brookline (CCB)	Brookline	Massachusetts
United States	NewBridge on the Charles	Dedham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	U.S. Highbush Blueberry Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver Enzymes	Measuring AST and ALT in blood samples	12 weeks after randomization
Other	Total and Direct Bilirubin	Measured in blood samples	12 weeks after randomization
Other	Fasting Glucose	Measured in blood samples	12 weeks after randomization
Other	Fasting Insulin	Measured in blood samples	12 weeks after randomization
Other	White Blood Cell Count	Measured in blood samples as part of complete blood count	12 weeks after randomization
Primary	Ambulatory Blood Pressure Monitoring	24-hour wake-time ambulatory blood pressure monitoring	12 weeks after randomization
Primary	Orthostatic Hypotension	Supine and standing blood pressure	12-weeks after randomization
Primary	Lower Extremity Functioning	Short Physical Performance Battery	12 weeks after randomization
Primary	Cognition	Cogstate Brief Battery of four core cognitive domains: processing speed, attention, visual learning, and working memory	12 weeks after randomization
Secondary	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
Secondary	Grip Strength	Bilateral grip strength measured by a dynamometer	12 weeks after randomization
Secondary	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
Secondary	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
Secondary	Cardiac Ectopy	Number of participants with atrial premature beats detected by a 24-hour Holter monitor	12 weeks after randomization
Secondary	Troponin T (HS)	Measured in blood sample	12 weeks after randomization
Secondary	High Density Lipoprotein Cholesterol	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Secondary	Total Cholesterol	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Secondary	Derived Low Density Lipoprotein Cholesterol	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Secondary	Triglycerides	Measured in fasted blood as part of a lipid panel	12 weeks after randomization
Secondary	Estimated Glomerular Filtration Rate (eGFR)	Measured in blood as part of basic metabolic panel	12 weeks after randomization
Secondary	Albumin-to-Creatinine Ratio	Measured in a spot urine sample to detect albuminuria	12 weeks after randomization
Secondary	Fructosamine	Measured in blood to estimate glucose levels over the previous 2-3 weeks.	12 weeks after randomization
Secondary	Free Fatty Acids	Measured in blood samples	12 weeks after randomization
Secondary	C-Reactive Protein (CRP)	Measured concentration in blood in response to inflammation	12 weeks after randomization
Secondary	C-terminal telopeptide of type 1 collagen	Measured in blood samples to assess bone turnover	12 weeks after randomization
Secondary	T-Cell Receptor Portfolio	Adaptive Immune Receptor Repertoire sequences in blood samples	12 weeks after randomization
Secondary	Immune System Diversity	Measure in blood samples to show diversity of immune sequences	12 weeks after randomization