Integrative Health Technologies, Inc,, 4940 Broadway, San Antonio, Texas 78209, USA.
Nutr J. 2011 Apr 14;10:32. doi: 10.1186/1475-2891-10-32.
The 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.
After 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).
There 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.
Following 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.
ClinicalTrials.gov NCT01114685.
美国外科医生总署的骨健康报告指出，美国的骨骼健康状况令人担忧，并发出了“行动呼吁”，以制定骨健康计划：（1）改善营养，（2）提高健康素养，（3）增加体育活动。本研究是对这一行动呼吁的回应。
在签署知情同意书后，158 名成年人同意在接受骨密度 DXA 测试、43 项化学血液测试面板和生活质量评估（藻钙 1）后，遵循为期六个月的开放式骨健康计划。最后一名受试者完成两周后，招募了第二组 58 名受试者，并遵循相同的计划，但使用了不同的骨健康补充剂（藻钙 2）。
两组在基线骨矿物质密度（BMD）或与 BMD 相关的变量（年龄、性别、体重、体脂百分比、脂肪量或去脂体重）方面无显著差异。两组志愿者和非志愿者之间，以及完成方案的志愿者和因失访而丢失的志愿者之间，BMD 或相关变量均无显著差异。与预期相比，两组的 BMD 平均年化百分率变化（MAPC）均显著为正[藻钙 1：1.15%，p=0.001；藻钙 2：2.79%，p=0.001]。两组的 MAPC 均较基线有所升高，但只有藻钙 2 的变化具有统计学意义[藻钙 1：0.48%，p=0.14；藻钙 2：2.18%，p<0.001]。藻钙 2 的 MAPC 显著大于藻钙 1（p=0.005）。两个计划中，完全依从和部分依从受试者之间的 MAPC 差异均有统计学意义（p=0.001 和 p=0.003）。两组均未发现 43 项血液化学测试面板的临床显著变化，也未发现生活质量自我报告的变化。
两组受试者分别按照骨健康补充剂的两种方案，坚持 6 个月的治疗计划，BMD 较预期均显著增加，且藻钙 2 的增加幅度明显大于藻钙 1。两组中，依从性增加与 BMD 的增加幅度更大有关。两组均未报告不良反应。
ClinicalTrials.gov NCT01114685。
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