Journal of Nutritional Sciences and Dietetics 2018. 4(1):.

Evaluating the effects of pine bark extract supplementation on bone turnover and the possible mechanisms of OPG/RANKL signaling in postmenopausal osteopenic women: a trial protocol
Seyed Bahman Panahande, Zhila Maghbooli, Arash Hossein-nezhad, Saeed Hosseini

Abstract


Introduction: Despite the high prevalence of osteopenia in post-menopausal women, the treatment of osteopenia is controversial. This study aims to evaluate the effects of Pine Bark Extract (PBE) supplementation on bone turnover in postmenopausal osteopenic women.

Methods and analysis: This randomized double-blind clinical trial will be conducted in postmenopausal osteopenic women in Shariati Hospital of Tehran University of Medical Sciences. Totally, 44 postmenopausal women with osteopenia were randomly recruited into two study groups; in Pine Bark Extraction supplementation (250 mg/d, n=22) or placebo (n=22). For the demographic data of all subjects, the past medical history which is a recorded measurement of bone turn-over markers (PINP, BAP, CTx and OPG/RANKL) will be determined before and after the intervention.

Ethics and dissemination: The research was performed after obtaining approval from the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1395.1408), in line with the Helsinki Declaration. Prior to the commencement of the study, a written informed consent form was signed and dated by participants and investigators. The results will be released at the right time.

Trial registration number: Pre-results, IRCT2015071123153N1

Key words:Pine Bark Extract, post-menopausal, women, osteopenia.

Introduction: Despite the high prevalence of osteopenia in post-menopausal women, the treatment of osteopenia is controversial. This study aims to evaluate the effects of Pine Bark Extract (PBE) supplementation on bone turnover in postmenopausal osteopenic women.

Methods and analysis: This randomized double-blind clinical trial will be conducted in postmenopausal osteopenic women in Shariati Hospital of Tehran University of Medical Sciences. Totally, 44 postmenopausal women with osteopenia were randomly recruited into two study groups; in Pine Bark Extraction supplementation (250 mg/d, n=22) or placebo (n=22). For the demographic data of all subjects, the past medical history which is a recorded measurement of bone turn-over markers (PINP, BAP, CTx and OPG/RANKL) will be determined before and after the intervention.

Ethics and dissemination: The research was performed after obtaining approval from the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1395.1408), in line with the Helsinki Declaration. Prior to the commencement of the study, a written informed consent form was signed and dated by participants and investigators. The results will be released at the right time.

Trial registration number: Pre-results, IRCT2015071123153N1


Keywords


Pine Bark Extract, post-menopausal, women, osteopenia.

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