Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: Protocol for a dose-response double-blinded placebo-controlled randomised trial

Chwan Li Shen, Huanbiao Mo, Shengping Yang, Shu Wang, Carol K. Felton, Michael D. Tomison, Ima Nirwana Soelaiman

Research output: Contribution to journalArticle

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Abstract

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 boneprotective 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-?B 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, ?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.

Original languageEnglish
Article number012572
JournalBMJ Open
Volume6
Issue number12
DOIs
Publication statusPublished - 1 Dec 2016

Fingerprint

Tocotrienols
Randomized Controlled Trials
Placebos
Safety
Bone and Bones
Health
Outcome Assessment (Health Care)
RANK Ligand
Bioethics
Postmenopausal Osteoporosis
Tocopherols
Bone Development
Cytoplasmic and Nuclear Receptors
Menopause
Dietary Supplements
Serum
Ethics
Bone Density
Osteoporosis
Alkaline Phosphatase

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women : Protocol for a dose-response double-blinded placebo-controlled randomised trial. / Shen, Chwan Li; Mo, Huanbiao; Yang, Shengping; Wang, Shu; Felton, Carol K.; Tomison, Michael D.; Soelaiman, Ima Nirwana.

In: BMJ Open, Vol. 6, No. 12, 012572, 01.12.2016.

Research output: Contribution to journalArticle

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