| Abstract
Objectives: Phytomedicine is widely suggested for the
prevention of chronic disease, but evidence for a favorable
effect on bone health is lacking. The present study will
investigate the Zingiber officinale (ZO) and Curcuma longa
L. (CL) supplementation effects on quality of life, body
composition, bone mineral density (BMD) and osteoporosis
related biomarkers and micro-RNAs in women with
postmenopausal osteoporosis (PMO).
Methods: This study protocol is designed as prospective
triple-blind randomized controlled trial. One hundred
and 20 patients with PMO will be enrolled in a 4 month,
prospective, triple-blind, placebo-controlled trial and
randomly assigned to four groups: ZO (500 mg b.i.d.) + CL
(500 mg b.i.d.) (ZO + CL); ZO (500 mg b.i.d.) + placebo CL
(b.i.d.) (ZO + P); placebo ZO (b.i.d.) + CL (500 mg b.i.d.)
(CL + P); and placebo ZO (b.i.d.) + placebo CL (b.i.d.)
(P + P). Quality of life, body composition and BMD will be
defined as the primary endpoints and osteoporosis related
serum biomarkers and circulating micro-RNAs will be
defined as the secondary endpoints. The ANCOVA statistical
method will be used to investigate the effect of the
interventional variables on the response variable.
Conclusion: To our knowledge, this trial is the first clinical
study exploring the effect of Ginger and turmeric on quality
of life, body composition, BMD and osteoporosis related
biomarkers and micro-RNAs in women with PMO. The
findings of this trial could be the basis for the development
of harmless and inexpensive preventive and therapeutic
approaches for PMO |