Dietary Intervention Targeting Inflammation, Motivation, and Engagement in Physical Activity in Sedentary, Older Adults With Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Engagement in Physical Activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Change in Engagement in Physical Activity
时间窗: Change between baseline and 12 week follow-up
Defined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up
次要结局
- Study Recruitment Feasibility(Through study completion, approximately 6 months)
- Change in Inflammatory Marker - Interleukin-6(Change between Baseline and 12 week follow-up)
- Change in Inflammatory Marker - Brain Derived Neurotrophic Factor(Change between Baseline and 12 week follow-up)
- Study Recruitment Feasibility(Through study completion, approximately 6 months)
- Change in Motivation(Change between baseline and 12 week follow-up)
- Change in Inflammatory Marker - C-Reactive Protein(Change between Baseline and 12 week follow-up.)
研究者
Courtney Millar
Assistant Scientist I
Hebrew SeniorLife