ABSORB (Amount of Blueberries So Older Adults Reap Benefits)
- Conditions
- AgingDepressive Symptoms
- Interventions
- Other: Freeze-dried Blueberry Powder
- Registration Number
- NCT05937165
- Lead Sponsor
- Hebrew SeniorLife
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5
- 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
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Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease
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Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions
-
Self-reporting history of type 1 or type 2 diabetes
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Self-reporting any history of substance or alcohol use disorder
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Allergy to blueberries
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Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs
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Are excessive tea or coffee consumers (e.g., >3 cups/day)
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Recent and consistent use of antibiotics
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Currently taking or advised during the intervention to take anti-depressants
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Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener
- All deviations must be approved by the study sponsor
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Higher Dose Freeze-dried Blueberry Powder Freeze-dried Blueberry Powder Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days. Standard Dose Freeze-dried Blueberry Powder Freeze-dried Blueberry Powder Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.
- Primary Outcome Measures
Name Time Method Urinary Flavonoid Biomarkers 3 days Change in total flavonoid metabolites found in the urine
Inflammatory Biomarker tumor necrosis factor alpha 3 days Change in tumor necrosis factor alpha
Inflammatory Biomarker interleukins 1B, 6, 8, 10 3 days Change in interleukins 1B, 6, 8, 10
Inflammatory Biomarker C-reactive Protein 3 days Change in serum C-reactive Protein
Inflammatory Biomarker interferon gamma 3 days Change in serum interferon gamma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hebrew Rehabilitation Center
🇺🇸Roslindale, Massachusetts, United States