ABSORB (Amount of Blueberries So Older Adults Reap Benefits)

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937165
• Other study ID #: Pro00069826
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Hebrew SeniorLife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Depression
• Depressive Symptoms

Intervention

Other:
• Freeze-dried Blueberry Powder
Three day consumption of two doses of freeze-dried blueberry powder

Locations

Country	Name	City	State
United States	Hebrew Rehabilitation Center	Roslindale	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew SeniorLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Flavonoid Biomarkers	Change in total flavonoid metabolites found in the urine	3 days
Primary	Inflammatory Biomarker C-reactive Protein	Change in serum C-reactive Protein	3 days
Primary	Inflammatory Biomarker interferon gamma	Change in serum interferon gamma	3 days
Primary	Inflammatory Biomarker interleukins 1B, 6, 8, 10	Change in interleukins 1B, 6, 8, 10	3 days
Primary	Inflammatory Biomarker tumor necrosis factor alpha	Change in tumor necrosis factor alpha	3 days