Abstract
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
Highlights
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
▪ minus the expected mean annualized percent change (MAPC) was greater than zero in AC-1 [1.15% (3.62), p < 0.001] and in AlgaeCal 2 (AC-2) [2.79% (3.57), p < 0.001];
▪ from baseline was greater in AC-2 [2.18% (3.58), than in AC-1 [0.48% (3.64), p = 0.005);
Summary
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. CER is a marked departure from the past research models that have focused on demonstrating superiority over placebos, instead of comparing the relative efficacy and safety of new therapeutic interventions [5]. This has often has led to approval of a number of “me too” interventions that rely on a company’s marketing skills as opposed to demonstration of superior safety and efficacy. Publication of the results of CER studies will require a paradigm shift in the scientific community where, traditionally, the use of placebo or control groups in studies significantly increases the chances for publication [6]
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