Changes in total body bone mineral density following a common bone health plan with two versions of a unique bone health supplement: a comparative effectiveness research study

Nutrition Journal

Research

Robert B Leckie¹  Harry A Croft²  Joel E Michalek³  Harry G Preuss⁴  Patti L Keith⁵  Monika Dapilmoto⁵  Gilbert R Kaats⁵  Samuel C Keith⁵  Nicholas V Perricone⁶ 

[1] Business and Healthcare Consultants, San Antonio, TX, USA;Croft Research Group, San Antonio, TX, USA;Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA;Department of Physiology, Georgetown University Medical Center, Washington, DC, USA;Integrative Health Technologies, Inc., 4940 Broadway, 78209, San Antonio, Texas, USA;Michigan State University College of Human Medicine, East Lansing, Michigan, USA;

关键词: Bone Mineral Density;    Bone Health;    Calcium Carbonate;    Strontium Ranelate;    Baseline Bone Mineral Density;   

DOI  :  10.1186/1475-2891-10-32

 received in 2010-05-04, accepted in 2011-04-14,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThe US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that: (1) improve nutrition, (2) increase health literacy and, (3) increase physical activity. This study is a response to this call to action.MethodsAfter signing an informed consent, 158 adults agreed to follow an open-label bone-health plan for six months after taking a DXA test of bone density, a 43-chemistry blood test panel and a quality of life inventory (AlgaeCal 1). Two weeks after the last subject completed, a second group of 58 was enrolled and followed the identical plan, but with a different bone-health supplement (AlgaeCal 2).ResultsThere were no significant differences between the two groups in baseline bone mineral density (BMD) or in variables related to BMD (age, sex, weight, percent body fat, fat mass, or fat-free mass). In both groups, no significant differences in BMD or related variables were found between volunteers and non-volunteers or between those who completed per protocol and those who were lost to attrition.Both groups experienced a significant positive mean annualized percent change (MAPC) in BMD compared to expectation [AlgaeCal 1: 1.15%, p = 0.001; AlgaeCal 2: 2.79%, p = 0.001]. Both groups experienced a positive MAPC compared to baseline, but only AlgaeCal 2 experienced a significant change [AlgaeCal 1: 0.48%, p = 0.14; AlgaeCal 2: 2.18%, p < 0.001]. The MAPC in AlgaeCal 2 was significantly greater than that in AlgaeCal 1 (p = 0.005). The MAPC contrast between compliant and partially compliant subjects was significant for both plans (p = 0.001 and p = 0.003 respectively). No clinically significant changes in a 43-panel blood chemistry test were found nor were there any changes in self-reported quality of life in either group.ConclusionsFollowing The Plan for six months with either version of the bone health supplement was associated with significant increases in BMD as compared to expected and, in AlgaeCal 2, the increase from baseline was significantly greater than the increase from baseline in AlgaeCal 1. Increased compliance was associated with greater increases in BMD in both groups. No adverse effects were reported in either group.Trial RegistrationClinicalTrials.gov NCT01114685

【 授权许可】

Unknown   
© Michalek et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.