ABSORB (Amount of Blueberries So Older Adults Reap Benefits)

Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Aging; Depressive Symptoms
• Intervention / Treatment: Other: Freeze-dried Blueberry Powder

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Roslindale, Massachusetts, United States, 02131
      • Hebrew Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Dose Freeze-dried Blueberry Powder; Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.	Other: Freeze-dried Blueberry Powder; Three day consumption of two doses of freeze-dried blueberry powder
Experimental: Higher Dose Freeze-dried Blueberry Powder; Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days.	Other: Freeze-dried Blueberry Powder; Three day consumption of two doses of freeze-dried blueberry powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Flavonoid Biomarkers	Change in total flavonoid metabolites found in the urine. The values for the metabolites represent the relative abundance of each metabolite, rather than absolute quantification, with higher values reflecting higher levels of total flavonoid metabolites in the urine.	Baseline and Day 3 of intervention
Inflammatory Biomarker C-reactive Protein	Change in serum C-reactive Protein	Baseline and Day 3 of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Biomarker Tumor Necrosis Factor Alpha	Change in tumor necrosis factor alpha	Baseline and Day 3 of intervention
Inflammatory Biomarker Interleukin 6	Change in interleukin 6	Baseline and Day 3 of intervention
Inflammatory Biomarker Interferon Gamma	Change in serum interferon gamma	Baseline and Day 3 of intervention

Collaborators and Investigators

• Sponsor: Hebrew SeniorLife

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: Pro00069826

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No