Abstract
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.
Bone fractures are preventable with the right interventions that involve not just nutrition by physical activity, nutritional knowledge and the right supplementation. Supplements are just that supplements and not a replacement for food.
Research Problem and Objectives:
The research was born out of two calls to actions: one by NIH’s Office of Dietary Supplements seeking to stimulate research to study the effectiveness of supplements on biomarkers associated with chronic disease and the other one was a call to action by the US Surgeon General asking for programs to be developed for bone health. The surgeon general asked that 3 components make up the programs: 1. Improved nutrition 2. Improve health literacy 3. Increase physical activity.
The research was to solve the problem reported by the surgeon general that by 2020, half of all Americans citizens older than age 50 will be at an increase for fractures due to the sedentary life style, absence of current information on bone health, and inadequate nutrition (1).
Method:
The methodology used was based on Comparative Effective Research studies as defined by the American College of Physicians. The CER is the evaluation of the relative clinical effectiveness, safety, and the cost of two or more medical services. CER studies not only compare different drugs, but healthcare plans that include life style modification such as diet, physical activity and complementary and alternative therapies that are often initiated without physician input. The research study decided not to put a placebo against the calcium supplement, but to use a secondary supplement to compare it too. Bias of selection of individuals was taken into account based on the knowledge of placebo vs. a supplement to improve bone health, as well as participants being paid to $2 not for participation, but to track relevant daily information and persons with vested interest in research. Two group research plans were created AC-1 (274 participants) and AC-2 (58 participants) that included Ca supplement 1 and 2 for each respectively, nutritional education, total bone density scan DXA, and biomarker tests. The program AC-1 was followed immediately by program AC-2 for a period of 6-months each (1-2).
Results:
The results were impressive comparing the two calcium (AC-1/AC-2) supplements to restoring or slowing the rate of bone loss density to even those at present in the market (Ca carbonate or citrate). The mean annual percentage change (MAPC) found in AC-2, as compared to AC-1, suggest that modifications made to the nutritional profile of AC-2, while holding all other components constant, provided additional benefits over and above the benefits provided by the other components of the plan (3-9). AC-1 and AC-2 experienced a significant positive MAPC in BMD, of AC-1: 1.15% and AC-2: 2.79%. AC-2 contains additional nutritional elements: vitamin C, as Ca ascorbate 25 mg, vitamin D (as Cholecalciferol) 20 mcg/800IU, Mg 175 mg, Boron 1.5 mg, and Vitamin K as K2, Delta MK-7, 50 mcg (2-9). In addition, there were no adverse reports in the quality of life reported or changes in blood panels. The only changes were an increase in bone density that was ascertained with the DXA scan at the end of the 6-month.
Conclusion and personal thoughts:
There is much that was taken into account to do this comparison research with a small budget and responding to a call to action of the surgeon general to help improve bone health in the US population to those greater than 55 years. The combination of the extra nutrients mixed with a calcium extracted from red algae is an innovative idea, but yet not fully known by enough people in the US as of 2022. The implementation of physical activity and the proper nutrition information to improve bone health is a must that goes hand in hand with a Calcium supplement. There is a health and nutritional crisis in the US that still needs to be resolved by government providing relevant and up to date nutritional information that does not involved political bias.
Works Cited:
Michalek et al.: 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 2011 10:32. Last accessed 5 7 2022.
https://nutritionj.biomedcentral.com/articles/10.1186/1475-2891-10-32