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Open Access Research

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

Joel E Michalek1, Harry G Preuss2, Harry A Croft3, Patti L Keith4, Samuel C Keith4, Monika Dapilmoto4, Nicholas V Perricone5, Robert B Leckie6 and Gilbert R Kaats4*

Author Affiliations

1 Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, TX., USA

2 Department of Physiology, Georgetown University Medical Center, Washington, DC USA

3 Croft Research Group, San Antonio, TX. USA

4 Integrative Health Technologies, Inc., 4940 Broadway, San Antonio, Texas, 78209 USA

5 Michigan State University College of Human Medicine, East Lansing, Michigan USA

6 Business and Healthcare Consultants, San Antonio, TX. USA

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Nutrition Journal 2011, 10:32  doi:10.1186/1475-2891-10-32

Published: 14 April 2011

Abstract

Background

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.

Methods

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).

Results

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.

Conclusions

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.

Trial Registration

ClinicalTrials.gov NCT01114685