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: Recruiting
• 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 6 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 (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Roslindale, Massachusetts, United States, 02131
      • Recruiting
      • Hebrew Rehabilitation Center
      • Contact: Alex Wolfe; Phone Number: 617-971-5492; Email: alexwolfe@hsl.harvard.edu

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 or pro-biotics
• Currently taking or advised during the intervention to take anti-depressants
• Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener

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	3 days
Inflammatory Biomarker C-reactive Protein	Change in serum C-reactive Protein	3 days
Inflammatory Biomarker interferon gamma	Change in serum interferon gamma	3 days
Inflammatory Biomarker interleukins 1B, 6, 8, 10	Change in interleukins 1B, 6, 8, 10	3 days
Inflammatory Biomarker tumor necrosis factor alpha	Change in tumor necrosis factor alpha	3 days

Collaborators and Investigators

• Sponsor: Hebrew SeniorLife

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 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 (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; 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