Effects of Blueberries in Older Adults

NCT05358210 | Completed

• 1 other identifier: 2021P001034
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Blood Pressure; Orthostatic Hypotension; Vascular Diseases

Keywords

Blueberries; Dates; Older Adults; Blood pressure; Fruit; Vascular health; Dietitian

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (18)

• Number of Self-Reported Falls

  Weekly for 12 weeks between baseline and follow-up

• Grip Strength

  12 weeks after randomization

• Sleep

  12 weeks after randomization

• Incontinence

  12 weeks after randomization

• Cardiac Ectopy

  12 weeks after randomization

Other Outcomes (5)

• Liver Enzymes

  12 weeks after randomization

• Total and Direct Bilirubin

  12 weeks after randomization

• Fasting Glucose

  12 weeks after randomization

Study Arms (2)

Blueberry Consumption

EXPERIMENTAL

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

Behavioral: Blueberry Consumption

Dried Date Consumption

ACTIVE COMPARATOR

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

Behavioral: Dried Date Consumption

Interventions

Blueberry Consumption BEHAVIORAL

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.

Blueberry Consumption

Dried Date Consumption BEHAVIORAL

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.

Dried Date Consumption

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years old
• Independent-living

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• U.S. Highbush Blueberry Council: collaborator

Study Sites (2)

Center Communities of Brookline (CCB)

Brookline, Massachusetts, 02446, United States

Location

NewBridge on the Charles

Dedham, Massachusetts, 02026, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic; Vascular Diseases

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Cardiovascular Diseases

Study Officials

• Kenneth J Mukamal, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Section Chief for Research

Model Details: Individual, parallel-design, randomized trial

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 3, 2022
• Study Start: April 20, 2022
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)