ISRCTN10942256进行中（未招募）不适用
The effect of a multivitamin supplement (Vitals+) on brain function, cognition, mood, and vasomotor symptoms in a perimenopausal woman: a proof-of-concept n = 1 deep-phenotyping study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •Female aged 45–55 years
- •Perimenopausal (as defined by NICE Menopause guidelines 2024) for at least 2 years
- •Free from major neuropsychiatric conditions (e.g., depression), neurological conditions (e.g. multiple sclerosis), and gynaecological conditions (e.g., endometriosis)
- •Able to provide informed consent
- •Willing to undergo the full study protocol, including 32 clinic visits, MRI scanning, and biological sample collection
排除标准
- •Currently taking hormone replacement therapy (HRT)
- •Use of any nutritional supplements within the last 3 months
- •Consumption of more than 1 portion of oily fish per month AND red blood cell omega-3 index >6%
- •Consumption of more than 4 portions of fruit and vegetables per day
- •Consumption of more than 4 portions of B-vitamin fortified foods per week
- •Contraindication to MRI (e.g. metallic implants, pacemaker, cochlear implant, severe claustrophobia)
- •Postmenopausal (no menstrual cycle for =12 months)
研究组 & 干预措施
The participant receives Vitals+, a commercially available multivitamin supplement (Heights, Braincare Limited, London), at a dose of two capsules per day for 12 weeks. The supplement contains 12 vitamins (thiamine/B1, riboflavin/B2, niacin/B3, pantothenic acid/B5, B6, biotin/B7, folate/B9 as 5-MTHF, B12 as methylcobalamin, vitamin A, vitamin C, vitamin D3, and vitamin E), 5 minerals (iron, zinc, selenium, chromium, and iodine), two omega-3 fatty acids from algae oil (EPA and DHA), and bilberry extract (36% anthocyanins). The supplement is an oral capsule.
干预措施: The participant receives Vitals+, a commercially available multivitamin supplement (Heights, Braincare Limited, London), at a dose of two capsules per day for 12 weeks. The supplement contains 12 vitamins (thiamine/B1, riboflavin/B2, niacin/B3, pantothenic acid/B5, B6, biotin/B7, folate/B9 as 5-MTHF, B12 as methylcobalamin, vitamin A, vitamin C, vitamin D3, and vitamin E), 5 minerals (iron, zinc, selenium, chromium, and iodine), two omega-3 fatty acids from algae oil (EPA and DHA), and bilberry extract (36% anthocyanins). The supplement is an oral capsule.
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