Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Hebrew SeniorLife

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.