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

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

Seaweeds in Human Health

“…In a double-blind cross-over trial, a preparation of calcium from oyster shell and heated seaweed extract (Cystophyllum fusiforme), providing 900-mg Ca per day, was shown to increase lumbar spine bone density of 58-year-old postmenopausal women after 6 and 24 months of supplementation, when compared to placebo. A later study run with another plant sourced form of calcium made by milling whole, live-harvested sea algae found on the South American coastline and provided within a general bone health plan including physical activity and other general dietary recommendations led to increased bone mineral density in adults aged 18-85 (Michalek et al, 2011). It was hypothesized that this form of calcium was better absorbed than calcium from other sources, since parathyroid hormone was decreased to a greater extent with this preparation than with milk in a cross-over trial run in eight young 18-19-year-old female volunteers (Ohgitani et al, 1997).…”

Fortification of yogurts with vitamin D and calcium enhances the inhibition of serum parathyroid hormone and bone resorption markers: A double blind randomized controlled trial in women over 60 living in a community dwelling home

“…This clinical investigation approach can be considered as lying within the conceptual scope of “Comparative Effectiveness Research (CER)” ( 12 ). So far, few studies have applied a CER design in the field of clinical nutrition, such as that comparing the effects of two plant-source forms of calcium supplements on bone mineral density ( 13 ).…”

Biochemical markers for assessment of calcium economy and bone metabolism: application in clinical trials from pharmaceutical agents to nutritional products

“…Although CER will pose challenges for medical and nutritional industries, it will present numerous opportunities to improve the information base supporting nutritional products, especially when they are integrated into other medical interventions ( 166 ) . Recent CER nutrition studies have been reported on the bone effects of several vitamin D and Ca supplement regimens ( 167 , 168 ) .…”