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临床试验/NCT05937165
NCT05937165已完成不适用

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

Hebrew SeniorLife2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
Urinary Flavonoid Biomarkers

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 65 years and older
  • Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points)

排除标准

  • 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

结局指标

主要结局

Urinary Flavonoid Biomarkers

时间窗: Baseline and Day 3 of intervention

Change in total flavonoid metabolites found in the urine. The values for the metabolites represent the relative abundance of each metabolite, rather than absolute quantification, with higher values reflecting higher levels of total flavonoid metabolites in the urine.

Inflammatory Biomarker C-reactive Protein

时间窗: Baseline and Day 3 of intervention

Change in serum C-reactive Protein

次要结局

  • Inflammatory Biomarker Tumor Necrosis Factor Alpha(Baseline and Day 3 of intervention)
  • Inflammatory Biomarker Interleukin 6(Baseline and Day 3 of intervention)
  • Inflammatory Biomarker Interferon Gamma(Baseline and Day 3 of intervention)

研究者

发起方
Hebrew SeniorLife
申办方类型
Other
责任方
Sponsor

研究点 (2)

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