An EEG Study to Investigate the Effect of High-dose Vitamin B6 Supplementation on Neural Activity in Relation to Depression and Anxiety Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Neural inhibition measured using Electroencephalography
研究概览
简要总结
This clinical trial investigates the effects of Vitamin B6 supplementation on neural inhibition using electroencephalography (EEG), in relation to depression and anxiety symptoms in participants from the general population with a relatively high level of symptoms at baseline. Researchers will compare a placebo group to high-dose Vitamin B6 to test the hypothesis that Vitamin B6 moves the excitation/inhibition balance towards inhibition.
详细描述
The primary question this trial aims to answer is:
- Compared to placebo, in people experiencing depression and anxiety symptoms, does high-dose Vitamin B6 supplementation change the excitation/inhibition balance towards inhibition as measured using electroencephalography (EEG)?
Secondary research questions are:
- Compared to placebo, does high-dose Vitamin B6 supplementation reduce symptoms of depression and anxiety?
- Do individuals with lower Vitamin B6 levels at baseline, as measured in blood plasma, show a larger effect of high dose Vitamin B6 on the EEG measures or symptoms?
- Compared to placebo, does high-dose Vitamin B6 intervention lead to an increase in hand grip strength? This is a possibility suggested to us by our prvious finding of reduced self reported 'postural disorder' by Vitamin B6 (Field et al., 2024), and by existing literature about the role of Vitamin B6 in muscle function.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age and under 41
- •Mild to moderate anxiety and/or depression
- •Normal or corrected to normal vision
排除标准
- •not taking daily dietary supplement containing >2 mg Vitamin B6
- •not taking medication that is a GABA agaonist (our team will check this with you)
- •not be pregnant
- •no medical history of epilepsy
- •no medical history of peripheral neuropathy
- •not taking the antibiotic Seromycin (prescribed for tuberclosis or urinary tract infection)
- •no history of brain injury or recent concussion
研究组 & 干预措施
Pyridoxal-5'-Phosphate supplement
100mg Vitamin B6 as pyridoxal-5-phosphate, daily with food
干预措施: Pyridoxal-5'-Phosphate supplement (Drug)
Microcrystalline Cellulose Placebo
Placebo capsule, daily with food
干预措施: Placebo Supplementation (Drug)
结局指标
主要结局
Neural inhibition measured using Electroencephalography
时间窗: From enrolment to the end of treatment 1 week later
次要结局
- Hand grip strength(From enrolment to the end of treatment 1 week later)
- Self reported anxiety (Screen for Adult Anxiety Related Disorders, SCAARED)(From enrolment to the end of treatment 1 week later)
- Self-reported depression symptoms (Depression, Anxiety, and Stress questionnire, DASS)(From enrolment to the end of treatment 1 week later)
- Vitamin B6 status(From enrolment to the end of treatment 1 week later)
研究者
David Field
Associate professor
University of Reading