The Effects of Wild Blueberries on Depressive Symptoms in Young Adults: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory-II (BDI-II)
研究概览
简要总结
This study aims to investigate the effects of a 6-week dietary intervention of 22 g freeze-dried whole wild blueberry powder. The outcomes include measures of depression, anxiety, anhedonia, cognitive function, and biomarkers of inflammation and oxidative stress.
详细描述
A randomized, double-blind, placebo-controlled, parallel-design study assessing the effects of a 6-week intervention of wild blueberry powder in young adults with depressive symptoms. A total of 60 participants will be randomly assigned to either 22 g blueberry powder or a matched placebo powder consumed daily with water. The severity of depression, anxiety, anhedonia, perceived stress, and quality of life will be measured at baseline and 6 weeks later. In addition, we will assess changes in cognitive function and transient mood 2 hours after consuming a single dose of blueberries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 24 years of age
- •Patient Health Questionnaire-9 score ≥ 10 and a score ≥ 2 on the sum of items 1 and 2
- •Willingness to provide blood samples
排除标准
- •Any medically significant condition (e.g. diabetes, endocrine or gastrointestinal disorders)
- •Taking medication (excluding hormonal contraception)
- •History of mental illness (excluding anxiety and unipolar depressive disorders)
- •Allergy to blueberries or any other Vaccinium species
- •Receiving psychotherapy or counselling
结局指标
主要结局
Beck Depression Inventory-II (BDI-II)
时间窗: 6 weeks
A validated 21-item self-rated scale for assessing depression severity. The scale ranges from 0 to 63 points with higher scores indicating more severe depressive symptomatology.
次要结局
- Snaith-Hamilton Pleasure Scale (SHAPS) - modified version(6 weeks)
- Brain-derived neutrophic factor (BDNF) in serum(6 weeks)
- Negative affect as measured by PANAS-X(6 weeks)
- Cognitive flexibility(6 weeks)
- Serum superoxide dismutase (SOD)(6 weeks)
- Serum total antioxidant capacity (TAC)(6 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(6 weeks)
- Composite Quality of Life Index(6 weeks)
- Positive affect as measured by PANAS-X(6 weeks)
- Interleukin-6 (IL-6) in serum(6 weeks)
- Uric acid in serum(6 weeks)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(6 weeks)
- Perceived Stress Scale (PSS-10)(6 weeks)
- C-reactive protein (CRP) in serum(6 weeks)
研究者
Prof Claire Williams
Professor
University of Reading