A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Verbal Memory
研究概览
简要总结
The goal of this clinical trial is to learn if daily omega-3 supplementation improves memory and cognitive function in perimenopausal and menopausal women aged 40-60 years. It will also assess whether omega-3 supplements influence menopausal symptoms, stress levels, and sleep patterns.
The main questions it aims to answer are:
- -Does omega-3 supplementation improve memory and cognitive performance?
- - Does omega-3 supplementation affect menopausal symptoms, stress, and perceived memory changes? 3- Are there any differences in sleep patterns during supplementation?
Researchers will compare omega-3 supplements to a placebo to see if omega-3 improves memory and cognition.
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be female and aged between 40-60 years
- •Be experiencing perimenopause or menopause
- •Access to reliable internet connection and a device to complete online questionnaires and cognitive assessments
- •Be prepared to take a daily omega-3 supplement or placebo for 12 weeks
- •Be prepared to complete pre- and post- intervention testing and questionnaires
- •Speak English fluently to confirm they can complete cognitive tests to the best of their ability
排除标准
- •Have diagnosed psychiatric or neurological condition (dementia, extreme depression, schizophrenia, bipolar disorder) which could affect cognitive function
- •Not currently be taking omega-3 supplements or regularly consuming fatty fish (1 portion per/week)
- •Be using hormone replacement therapy (HRT)
- •Have severe dietary restrictions
- •Have a history of stroke, cardiovascular disease or diabetes, as these conditions influence cognitive health
- •Are unable to commit to both baseline and follow-up tests after the 12-week period
- •Pregnant or breastfeeding
研究组 & 干预措施
Algea Omega-3 supplements (950mg DHA, 350mg EPA) (Cytoplan Ltd- high strenght)
干预措施: A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Algae Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal Women (Dietary Supplement)
Placebo (1000mg high oleic sunflower oil) (Phytoppharma.eu)
干预措施: A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Algae Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal Women (Dietary Supplement)
结局指标
主要结局
Verbal Memory
时间窗: From baseline to completion, up to 31 days
Change in Memory scores from baseline to post-intervention, Rey Auditory Verbal Learning Test (RAVLT)
Working memory
时间窗: From baseline to completion, up to 31 days
Change in memory from baseline to completion using the Digit Span Test
Verbal Adaptation
时间窗: From baseline to completion, up to 31 days
Change in verbal adaptation from baseline to completion using the Stroop Test
次要结局
- Change in menopausal symptoms (quality of life)(From baseline to completion, up to 31 days)
- Change in subjective memory function(From baseline to completion, up to 31 days)
- Dietary patterns(From baseline to completion, up to 31 days)
- Sleep patterns(Baseline (Week 0; 7-day recording period prior to intervention)End of intervention (Week 12; 7-day recording period))
- Stress levels(From baseline to completion, up to 31 days)
研究者
Magali Chohan
Senior Lecturer
St. Mary's University, Twickenham