Effects of Blueberries in Older Adults

NCT ID: NCT05358210

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2024-05-22

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.

Conditions

Blood Pressure; Orthostatic Hypotension; Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Blueberry Consumption

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

Group Type: EXPERIMENTAL

Blueberry Consumption

Intervention Type: 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.

Dried Date Consumption

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

Group Type: ACTIVE_COMPARATOR

Dried Date Consumption

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Highbush Blueberry Council

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Mukamal

Associate Section Chief for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth J Mukamal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Center Communities of Brookline (CCB)

Brookline, Massachusetts, United States

NewBridge on the Charles

Dedham, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2021P001034

Identifier Type: -

Identifier Source: org_study_id