Ginger (Zingiber officinale) and turmeric (Curcuma longa L.) supplementation effects on quality of life, body composition, bone mineral density and osteoporosis related biomarkers and micro-RNAs in women with postmenopausal osteoporosis: a study protocol for a randomized controlled clinical trial.

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 (ZO) and 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.