ABSORB (Amount of Blueberries So Older Adults Reap Benefits)

NCT ID: NCT05937165

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-11-25

Brief Summary

This randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.

Detailed Description

Blueberries are a rich source of anti-oxidants and dietary fiber, and are recommended to consume as a part of a healthy diet. Regular consumption of blueberries as a source of dietary antioxidants may be an effective way to lower inflammation in older adults, who commonly have higher levels of inflammatory markers. However, older adults typically have a decreased efficiency of nutrient absorption and may need a higher dose of blueberries to absorb enough of the flavonoids needed to reap their benefits on inflammation. Thus, it is important for preliminary studies to pre-determine an appropriate dose of blueberry flavonoids specifically for older adults. This study aims to evaluated the preliminary impact of freeze-dried blueberry powder consumption on flavonoid bioavailability and inflammatory biomarkers in older adults. This will be an individual-level, unblinded, randomized, cross over pilot study in 5 older adults with minor levels of depressive symptoms. Eligible participants will collect a 24 hour urine sample, and then come in for the baseline assessments and provide a blood sample. Next they will be randomized to consume either the higher dose (48 g/day, equivalent ~ 2 cups of fresh blueberries) or the lower dose (24 g/day, equivalent ~1 cup of fresh blueberries) for 3 days. After 3 days they will begin collecting a 24 hour urine sample, and come in to repeat the baseline assessments and provide a blood sample. After a two week wash out period, participants will repeat the same baseline and follow-up assessments while consuming the other powder.

Conditions

Depressive Symptoms; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Dose Freeze-dried Blueberry Powder

Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.

Group Type: ACTIVE_COMPARATOR

Freeze-dried Blueberry Powder

Intervention Type: OTHER

Three day consumption of two doses of freeze-dried blueberry powder

Higher Dose Freeze-dried Blueberry Powder

Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days.

Group Type: EXPERIMENTAL

Freeze-dried Blueberry Powder

Intervention Type: OTHER

Three day consumption of two doses of freeze-dried blueberry powder

Interventions

Freeze-dried Blueberry Powder

Three day consumption of two doses of freeze-dried blueberry powder

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women aged 65 years and older
• Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points)

Exclusion Criteria

• Unwilling to follow the study protocol
• Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19)
• Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders
• Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease
• Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions
• Self-reporting history of type 1 or type 2 diabetes
• Self-reporting any history of substance or alcohol use disorder
• Allergy to blueberries
• Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs
• Are excessive tea or coffee consumers (e.g., >3 cups/day)
• Recent and consistent use of antibiotics
• Currently taking or advised during the intervention to take anti-depressants
• Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener

• All deviations must be approved by the study sponsor

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew SeniorLife

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hebrew Rehabilitation Center

Roslindale, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00069826

Identifier Type: -

Identifier Source: org_study_id