The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change in Cognitive function
研究概览
简要总结
Participants will be randomly assigned to one of three treatment groups to receive soyafoods (Alpro drinks) providing a low (<10 mg), medium (35mg) or high-dose (60 mg) of isoflavones daily for a period of 12 weeks. The group receiving <10mg isoflavones daily will serve as a low-dose control group. Women will be asked to avoid consuming any additional soya foods during the study.
Dietary intake will be assessed at baseline using the validated food frequency questionnaire a 4 day food diary will be completed at baseline and post-intervention. Weight and height will be measured and a general health & lifestyle questionnaire will also be completed by participants at baseline. Cognitive function will be assessed at baseline and post-intervention using the well validated and widely used computerised test battery system. Menopausal symptoms, quality of life, mood, stress and coping will also be assessed.
Plasma concentrations of the soya isoflavones genistein and daidzein will be measured to assess compliance. Circulating concentrations of equol (a daidzein metabolite), will also be measured to investigate associations between equol and cognition and menopausal symptoms as a potential mechanism for the efficacy of soya.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •apparently healthy
- •within 7 years postmenpopausal with the absence of vaginal bleeding for at least 1 year
- •≥ 24 in mini mental state examination
- •not suffering from psychiatric distress as assessed using GHQ28 questionnaire
排除标准
- •surgically induced menopause
- •habitual consumers of soys foods (> 2 serves/week)
- •currently using hormone therapy
- •currently on isoflavone supplements
- •antibiotics use within last 3 months
- •use of psychoactive medication
- •history of CVD, cancer, diabetes, thyroid, renal or kidney disease, alcohol or drug abuse
- •red-green colour blindness
研究组 & 干预措施
Low isoflavone
Alpro soya drinks containing 10 mg isoflavones per day
干预措施: Alpro soya drinks (Dietary Supplement)
Medium isoflavone
Alpro soya drinks containing 35 mg isoflavones per day
干预措施: Alpro soya drinks (Dietary Supplement)
High isoflavone
Alpro soya drinks containing 60 mg isoflavones per day
干预措施: Alpro soya drinks (Dietary Supplement)
结局指标
主要结局
Change in Cognitive function
时间窗: Change at Week 12 from baseline
Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB)
次要结局
- Change in Coping(Change at Week 12 from baseline)
- Change in Quality of Life(Change at Week 12 from baseline)
- Change in Mood(Change at Week 12 from baseline)
- Change in Stress(Change at Week 12 from baseline)
- Change in Menopausal symptoms(Change at Week 12 from baseline)