Clinical trial NCT05937165: ABSORB (Amount of Blueberries So Older Adults Reap Benefits)
Official title: Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Aging
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 6
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Urinary Flavonoid Biomarkers
timeFrame: 3 days
measure: Inflammatory Biomarker C-reactive Protein
timeFrame: 3 days
measure: Inflammatory Biomarker interferon gamma
timeFrame: 3 days
measure: Inflammatory Biomarker interleukins 1B, 6, 8, 10
timeFrame: 3 days
measure: Inflammatory Biomarker tumor necrosis factor alpha
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roslindale
country: United States
facility: Hebrew Rehabilitation Center
state: Massachusetts
Study officials:
References: