Blueberries, Inflammation, Motivation, and Physical Activity

Depressive Symptoms Clinical Trial

Official title:

Dietary Intervention Targeting Inflammation, Motivation, and Engagement in Physical Activity in Sedentary, Older Adults With Depressive Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05735587
• Other study ID #: Pro00064749
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: December 31, 2024

Study information

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

Clinical Trial Summary

The purpose of this study is to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberry to modulate inflammation-driven lack of motivation in 40 sedentary, older adults with depressive symptoms.

Description:

The investigators will conduct a 14 week, single-site, randomized, double-blind, parallel pilot study in 40 sedentary, older adults with depressive symptoms. Participants will first enter a 2-week washout period where they will avoid consumption of foods high in fiber and anthocyanins (e.g., blueberries) and will also be wearing an activity monitor. Participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (~600 mg of anthocyanins and ~8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks.

At baseline, participants will be undergo assessments for mood/well-being, relevant symptoms, motivation to engage in physical activity, and provide a blood sample for the evaluation of inflammatory biomarkers. For the entire duration of the study, participants will continue to wear the activity monitor. After 4, 6, 8 and 12 weeks of consuming the powder there will be study visits that assess mood/well-being, relevant symptoms, motivation to engage in physical activity and compliance with the intervention. Additionally, a blood sample for the evaluation of inflammatory makers will be taken after 6 and 12 weeks of the intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged =65 years

• Self-reporting = 8 hours of sitting per/day (e.g., sedentary behavior)

• Depressive symptoms (defined as =4 and <16 points on the center for epidemiological studies depression-scale)

Exclusion Criteria:

• Unwilling to follow the study protocol

• A median daily step count >7,500 steps per day (as measured by the ActiGraph), or per discretion of the PI

• Cognitive impairment (defined as Montreal Cognitive Assessment, MoCA <22 points)

• Self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders, or per discretion of the PI

• Self-reporting type 1 or type 2 diabetes

• Allergic to intervention or control products

• Recent use (within the last 3 months) of antibiotics, or per discretion of the PI

• Recent use (within the last 3 months) of pro-biotics, or per discretion of the PI

• Current substance use disorder (Drug Abuse Screening Test, DAST-10>2 points)

• Current alcohol use disorder (Alcohol Use Disorders Identification Test - Consumption, AUDIT-C=4 points)

• Unstable anti-depressant use (e.g., change in medication within last 3-6 months), or per discretion of the PI

• Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener)

• Current psychosis (via the Psychosis and Hallucinations Questionnaire, PHQ>12 points)

• Manic symptoms (assessed by the Mood Disorder Questionnaire, MDQ >5 points)

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Inflammation

Intervention

Other:
• Freeze-dried Blueberry Powder
Participants will be asked to consume 48 grams of freeze-dried blueberry powder (~ equivalent to 2 cups of fresh blueberries) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
• Placebo Powder
Participants will be asked to consume 48 grams of a nutritionally matched placebo powder (that does not contain fiber or anthocyanins) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.

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	Engagement in Physical Activity	Defined as median daily-step count over intervention	Up to 12 weeks
Secondary	Study Recruitment Feasibility	Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm)	Through study completion, approximately 6 months
Secondary	Motivation	Motivation to engage in physical activity will be assessed via self-report questionnaire, Motives for Physical Activities Measure-Revised (range 0-30 points, with higher scores indicating higher levels of motivation).	Up to 12 weeks
Secondary	Inflammatory Marker - C-Reactive protein	Up to 12 weeks	C-reactive protein (mg/dL) will be measured in blood collected from participants.
Secondary	Inflammatory Marker - Interleukin-6	Up to 12 weeks	Interleukin-6 (pg/mL) will be measured in blood collected from participants.
Secondary	Inflammatory Marker - Brain derived neurotrophic factor	Up to 12 weeks	Brain derived neurotrophic (pg/mL) factor will be measured in blood collected from participants.