Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI
Từ khóa
trừu tượng
Sự miêu tả
Micronutrients (including vitamins, minerals and certain polyunsaturated fatty acids) are required by the brain for normal functioning and, with few exceptions, can only be obtained through dietary sources. Research into degenerative diseases of aging have linked mitochondrial aging and DNA damage caused by micronutrient deficiency to greater incidence of cognitive decline and stroke, among other diseases, in the general population, particularly in those consuming food rich in fats and carbohydrates but poor in micronutrient content. Other research focusing on cognition, behaviour and mood state has associated micronutrient deficiencies with a wide range of neurological conditions including Alzheimer's Disease, Parkinson's Disease, multiple sclerosis, autism spectrum disorders, depression, fatigue and schizophrenia. There have however been very few studies using micronutrient interventions in post-acute human TBI. In a study with thirty retired American Football players an intervention including supplementation with a broad-spectrum multivitamin, omega-3 fish oils and a number of other substances resulted in significant percentile score improvements in almost half of the participants (n=100) across a broad range of cognitive measures. Findings demonstrated that micronutrient intervention can result in significant measurable improvements in those with TBI many years following the initial insult. A normative study will be conducted with three groups assigned to Vit D, Vit C and multivitamin arms (N = 60) tested at baseline on cognitive function and post-intervention. The TBI study will recruit three groups of individuals with post-acute traumatic brain injuries and measure whether there is improved cognitive outcomes (measured by test-retest on a cognitive battery) associated with the supplements shown to be most effective in the pilot study.
ngày
Xác minh lần cuối: | 11/30/2019 |
Đệ trình đầu tiên: | 12/21/2016 |
Đăng ký ước tính đã được gửi: | 01/22/2017 |
Đăng lần đầu: | 01/25/2017 |
Cập nhật lần cuối được gửi: | 12/01/2019 |
Cập nhật lần cuối đã đăng: | 12/02/2019 |
Ngày bắt đầu nghiên cứu thực tế: | 09/30/2017 |
Ngày hoàn thành chính ước tính: | 08/31/2020 |
Ngày hoàn thành nghiên cứu ước tính: | 08/31/2020 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin
Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish Oil
Giai đoạn
Nhóm cánh tay
Cánh tay | Can thiệp / điều trị |
---|---|
Experimental: Multivitamin Swisse Womens 50+ Ultivite Multivitamin. Once daily. | |
Experimental: Omega-3 Fatty Acids Holland and Barrett Triple Strength Omega-3 Fish Oils. Once Daily | |
No Intervention: Control Treatment as usual (cognitive rehabilitation, occupational therapy, physiotherapy; as required) |
Đủ tiêu chuẩn
Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
Giới tính đủ điều kiện để nghiên cứu | All |
Chấp nhận tình nguyện viên lành mạnh | Đúng |
Tiêu chí | Inclusion Criteria: - First and only traumatic brain injury. - Complex mild to moderate injury. - 3-24 months post-injury Exclusion Criteria: - Unable to give informed consent. - Already taking micronutrient/fatty acid supplements. - Hemianopia - Hemiplegia. - Pregnant or breastfeeding. - Diagnosed with clinically low blood pressure, diabetes, or disease of neurodegeneration. |
Kết quả
Các biện pháp kết quả chính
1. Performance on cognitive test measures (a battery of standardized tests; memory, executive function, social cognition, general intelligence, learning and processing speed) [Three time points: baseline (T1), 8 weeks (T2) and 22 weeks (T3)]
Các biện pháp kết quả thứ cấp
1. Average dietary intake of micronutrients and fatty acids [Data collected at four time points (3 day diaries) during participant's involvement in the study via participants filling in paper food diary]