Assessment of Primary Osteoporosis Status in the Postmenopausal Women of Tabriz and the Effect of Curcumin Nanomicelles, Nigella sativa Oil, and Curcumin Nanomicelles and Nigella sativa Oil Soft Capsules on Cellular-Molecular and Clinical Outcomes: A Study Protocol

Objectives: To determine the status of primary osteoporosis and evaluate the effects of curcumin nanomicelles, Nigella sativa oil, and curcumin nanomicelles plus N. sativa oil compared to placebo on cellular-molecular and clinical outcomes. Materials and Methods: The study protocol will be implemented in two phases. The first phase is a cross-sectional study aiming at determining the prevalence of primary osteoporosis and its risk factors, especially cellular-molecular factors in 528 postmenopausal women aged 50-65 years in Tabriz, Iran through simple random sampling. The second phase is a triple-blind factorial randomized controlled clinical trial. In this phase, patients with primary osteoporosis, identified with dual-energy X-ray absorptiometry, will be randomly divided into equal four groups of 30 individuals in a triple-blind factorial randomized controlled trial. The four group included N. sativa oil soft capsules (one capsule 1000 mg/d) and placebo- curcumin nanomicelles, curcumin nanomicelles soft capsules (one capsule 80 mg/d) and placebo-N. sativa, N. sativa oil, and curcumin nanomicelles soft capsules, and both placebos for six months. Results: The prevalence of primary osteoporosis and its relationship with several parameters will be determined in phase 1, including socio-demographic-obstetric-medical characteristics, anthropometric indices, body composition, lifestyle, osteoporosis-related microRNAs, inflammatory and oxidative biomarkers, bone turnovers, and some gene polymorphisms. Finally, changes in mean bone mineral density (BMD), bone turnovers, inflammatory and oxidative biomarkers, and osteoporosis-related microRNAs will be evaluated in phase 2. Conclusions: The present study can significantly contribute to the prognosis of the disease and the selection of an appropriate herbal supplement given the cost-effectiveness of herbal compounds as pharmaceutical adjuvants.