A Randomized Controlled Trial to Determine the Effects of Curcumin and Epigallocatechin Gallate Supplementation on Serum Brain Derived Neurotrophic Factor and Mood Disturbance in Adults
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in total distress as measured via DASS-21 total score.
研究概览
简要总结
The goal of this randomized placebo controlled trial is to examine mood disturbance and serum brain derived neurotrophic factor (BDNF) in people (age 18-50) with DASS-21 subscale scores >9. The main questions it aims to answer are:
Does curcumin and EGCG supplementation improve mood disturbance symptomology? Does curcumin and EGCG supplementation increase serum BDNF? Researchers will compare intervention versus placebo.
Participants will consume an 8-week supplement of both:
- 1,330mg/day curcumin
- 350mg/day epigallocatechin gallate (EGCG)
详细描述
Clinical assessments will include phlebotomy (completed at weeks 0 and 8) and questionnaires which will be completed at weeks 0, 4, and 8 to assess changes in mood disorder symptomology and serum BDNF. 3 days of 24-hour diet recalls will be collected at weeks 0, 4 and 8. Daily reminders via Emitrr will be sent daily to ensure adherence to supplementation.
This is an 8-week randomized placebo controlled trial looking at mood disturbance and serum BDNF in moderately depressed adults aged 18-50. Participants will be randomized into the intervention group or placebo with the intervention group consuming 1,330mg/day curcumin and 350mg/day EGCG. Baseline mood disturbance questionnaires (DASS-21, GAD-7, GSAQ, IPAQ) and serum BDNF will be taken prior to intervention and again after intervention.
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
- Double (Participant, Investigator)
盲法说明
This is a double-blinded study with masking of participants and investigator using computer generated allocation sequences and sealed treatment and placebo supplement bags.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults age 18-50
- •Depression subscale score of >9/21 on the DASS-21
- •No change in medications or supplements over the past 3 months
- •Can read and speak English
排除标准
- •Currently consume curcumin or green tea daily
- •Currently, pregnant, nursing, or trying to become pregnant
- •Currently diagnosed with a perimenopausal disorder
结局指标
主要结局
Changes in total distress as measured via DASS-21 total score.
时间窗: 8-weeks
The DASS-21 (Depression Anxiety and Stress Scale) Total ranges from 0 to 63, with lower numbers indicating less distress
Changes in serum brain derived neurotrophic factor (BDNF).
时间窗: 8-weeks
Serum BDNF will be measured via commercial ELISA kits. Higher levels of serum BDNF are optimal.
次要结局
- Changes in DASS-21 subscales (depression, anxiety, stress).(8-weeks)
- Changes in subjective physical activity.(8-weeks)
- Changes in fasting alanine aminotransferase (ALT)(8-weeks)
- Changes in subjective sleep quality.(8-weeks)
- Changes in fasting aspartate aminotransferase (AST)(8-weeks)
- Changes in diet quality.(8-weeks)
- Number of Participants who report daily adherence to supplementation intake(8-weeks)
研究者
Aidan Cavanah
Graduate Assistant
Auburn University