The Effect of Stingless Bee Honey on BDNF, Oxidative Stress, Depressive Symptoms and Verbal Learning and Memory in Major Depressive Disorders: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Depressive symptoms
研究概览
简要总结
The goal of this clinical trial is to learn if stingless bee honey can be an augmentation supplement in Major Depressive Disorder (MDD) in adults. It will also learn about the adverse effects of the honey. The main questions it aims to answer are:
- Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD?
- Are there any effects of SBH on BDNF between intervention and control groups in MDD?
- Are there any effects of SBH on oxidative stress between intervention and control groups in MDD?
- Are there any effects of SBH on verbal learning and memory between intervention and control groups in MDD?
There is no placebo.
Participants will:
Take stingless bee honey or nothing every day for 2 months Visit the clinic once every 4 weeks for checkups and tests Report adherence and adverse effects of stingless bee honey on a self-reported online questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with ages 18 to 65
- •with Major Depressive Disorder with scores of Beck Depression Inventory Malay version equal or more than 11
排除标准
- •Women in pregnancy or breast-feeding.
- •Patients who with honey allergy or stingless bee honey allergy.
- •Currently taking honey not limited to stingless bee honey or taken honey not limited to stingless bee honey in the past one month.
- •comorbidity either with generalized anxiety disorder,
- •panic disorder,
- •social anxiety disorder,
- •bipolar disorder,
- •substance-use disorder,
- •suicidal ideation or attempt,
- •dementia,
- •Alzheimer disease,
- •diabetic,
- •hypertension,
- •chronic kidney disease
结局指标
主要结局
Depressive symptoms
时间窗: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Depressive symptoms will be assessed using Beck Depression Inventory Malay-version questionnaire, For total score, no depression (1 - 10); mild to moderate (11 -20); moderate to severe (21 - 30); severe (31 - 40); very severe (41 - 63).
Depressive symptoms
时间窗: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Depressive symptoms will be assessed using Beck Depression Inventory Malay-version questionnaire, For total score, no depression (1 - 10); mild to moderate (11 -20); moderate to severe (21 - 30); severe (31 - 40); very severe (41 - 63).
次要结局
- Oxidative stress(Before intervention, at week 4 during the intervention, at week 8 of the intervention)
- Brain derived neurotrophic factors, BDNF(Before intervention, at week 4 during the intervention, at week 8 of the intervention)
- Verbal learning and memory(Before intervention, at week 4 during the intervention, at week 8 of the intervention)
- Serum Interleukin-6(Before intervention, at week 4 during the intervention, at week 8 of the intervention)
- Verbal learning and memory(Before intervention, at week 4 during the intervention, at week 8 of the intervention)
- Oxidative stress(Before intervention, at week 4 during the intervention, at week 8 of the intervention)
- Brain derived neurotrophic factors, BDNF(Before intervention, at week 4 during the intervention, at week 8 of the intervention)
研究者
Ong Wailoon
Student of Master of science in medical physiology
Hospital Universiti Sains Malaysia