|Assessment of Primary Osteoporosis Status in Postmenopausal Women of Tabriz and effect of three interventions (Curcumin-nanomicelles, Nigella Sativa oil, and Curcumin-nanomicelles & Nigella sativa oil soft capsules) on Cellular- Molecular and Clinical Outcomes: A Study Protocol|
|Somayeh Abdolalipour1, Mojgan Mirghafourvand2, Majid Mobasseri3, Sakineh Mohammad-alizadeh4, Alireza Ostadrahimi1, Neda Dolatkhah5, Seyed Kazem Shakouri5, Safar Farajnia6, Azizeh Farshbaf-Khalili5|
|1Nutrition Research Center, Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran
2Social Determinants of Health Research Center, Tabriz University of Medical sciences, Tabriz, Iran
3Endocrinology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
4Social determinants of Health Research Center, Tabriz University of Medical sciences, Tabriz, IR Iran
5Aging Research Institute, Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
6Biotechnology Research center, Tabriz University of Medical Sciences, Tabriz, IR Iran
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Keywords : Postmenopausal Osteoporosis, Menopause, Health promotion life style, quality of life, Dual-energy X-ray absorptiometry, Curcumin, Nigella sativa, Bone turnovers, Inflammatory and oxidative stress biomarkers, Genetic polymorphisms
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Objectives: To determine the status of primary osteoporosis and evaluate the effects of Curcumin nanomicelles (Cur-n), Nigella sativa (N.S) oil, and Cur-n plus N.S oil compared to placebo on cellular-molecular and clinical outcomes.
Materials and Methods: This is a study protocol which will be implemented in two phases. The first phase will be a cross-sectional study aiming to determine the prevalence of primary osteoporosis and its risk factors specially related cellular-molecular factors in 528 postmenopausal women aged 50-65 years in Tabriz, Iran through simple random sampling. Second phase will be a triple blind factorial randomized controlled clinical trial. In this phase, patients with primary osteoporosis identified with dual-energy X-ray absorptiometry (DEXA) will be randomly divided into equal four groups of 30-individual in a triple blind factorial randomized controlled trial: N.S oil soft capsules (one capsule 1000 mg / day) & placebo- Cur-n, Cur-n soft capsules (one capsule 80 mg/ day) & placebo- N.S, N.S oil and Cur-n soft capsules, and both placebos for six months.
Results: Prevalence of primary osteoporosis and its relationship with socio-demographic -obstetric-medical characteristics, anthropometric indices, body composition, lifestyle, osteoporosis related micro RNAs, inflammatory and oxidative biomarkers, bone turnovers, and some gene polymorphisms will be determined in phase-1. Change in mean bone mineral density, bone turnovers, inflammatory and oxidative biomarkers, osteoporosis related micro RNAs will be evaluated in phase-2.
Conclusions: The present study can contribute significantly to the prognosis of the disease and the selection of an appropriate herbal supplement given the cost-effectiveness of herbal compounds as pharmaceutical adjuvants.
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