Blueberries, Gut Microbiota, and Metabolites in Depressed Older Adults - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Depressive Symptom Severity
研究概览
简要总结
This study aims to investigate the impact of daily freeze-dried blueberry powder consumption on the gut microbiota, fecal short chain fatty acids, and depressive symptom severity in 40older, sedentary adults with depressive symptoms.
详细描述
This study is an ancillary project to a currently funded randomized, placebo-controlled 12-week intervention in older, sedentary adults with depressive symptoms (IRB# Pro00064749). This specific project proposes distinct aims to the trial by gathering preliminary data on the synergistic impact of dietary fiber and anthocyanins (via freeze-dried blueberry powder) on the gut-microbiota, gut-derived metabolites, and depressive symptoms in older adults.
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 depressive symptom severity and provide a fecal sample for gut microbiota and short chain fatty acid measurement. After 4, 8, and 12 weeks of consuming the powder there will be study visits that assess depressive symptom severity. Additionally, a final fecal sample will be taken after 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
Depressive Symptom Severity
时间窗: Change between baseline and 12 weeks
Severity of depressive symptoms will be measured before and after the intervention with the Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.
次要结局
- Abundance Microbes(Change between baseline and 12 week follow-up)
- Fecal Short Chain Fatty Acids (i.e., Butyrate)(Percent change between baseline and 12 week follow-up)
研究者
Courtney Millar
Assistant Scientist I
Hebrew SeniorLife