Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose–response double-blinded placebo-controlled randomised trial
| Autor: | Michael D. Tomison, Shu Wang, Ima Nirwana Soelaiman, Chwan-Li Shen, Shengping Yang, Huanbiao Mo, Carol K Felton |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
intervention trial Osteoporosis 030209 endocrinology & metabolism Placebo Antioxidants Bone and Bones 03 medical and health sciences 0302 clinical medicine Quality of life N-terminal telopeptide Bone Density Internal medicine Protocol Medicine oxidative stress Humans 030212 general & internal medicine tocotrienols Osteoporosis Postmenopausal Aged Bone mineral Gynecology Aged 80 and over Nutrition and Metabolism bone turnover marker Dose-Response Relationship Drug business.industry General Medicine Middle Aged medicine.disease osteoporosis Menopause Postmenopause Liver Research Design Dietary Supplements Female Liver function women business Biomarkers Biomedical sciences |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | Introduction Osteoporosis is a major health concern in postmenopausal women, and oxidative stress contributes to the development of bone loss. Cellular studies and ovariectomised rat model mimicking bone loss in postmenopausal women show the bone-protective effect of tocotrienols (TTs) with antioxidant capability. We aim to access the safety and efficacy of TT consumption for bone health in postmenopausal women. Methods and analysis In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinary N -terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2’-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. ‘Intent-to-treat’ principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ 2 analysis and regression will be used for comparisons. Ethics and dissemination This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or nutrition and international conferences. Trial registration number NCT02058420; results. |
| Databáze: | OpenAIRE |
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