A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements

Study Overview
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Brief Summary
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A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.

Detailed Description
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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: improve nutrition, increase health literacy and, increase physical activity. The purpose of this study was to use a comparative effective research model to compare 6-month changes in bone mineral density (BMD)in two study groups. Both followed the same bone health plan that contained the three components listed above with the same plant-source calcium supplement, but enhanced with different levels of calcium, vitamin D3, vitamin K and magnesium.

Official Title
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Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study

Conditions
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Osteopenia

Intervention / Treatment
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* Dietary Supplement: AlgaeCal-1
* Dietary Supplement: AlgaeCal-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation. Exclusion Criteria: Younger the 18 years of age, and Recommendations not to participate from their physicians.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effects of taking AlgaeCal-1<br>Following a bone health plan with Algae-cal-1 supplement | Dietary Supplement: AlgaeCal-1<br>* Daily consumption of 7 capsules containing bone health ingredients<br>|
| Active Comparator: Effects of taking AlgaeCal-2<br>Following a bone-health plan while consuming AlgaeCal 2 | Dietary Supplement: AlgaeCal-2<br>* Taking 7 capsules a day for six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Bone Mineral Density (BMD) | Measurements of bone mineral density were conducted at baseline and 6 months from baseline in two different study groups following the same bone-health behavior modification plan, but with different versions of a bone-health calcium supplement. | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups | Study subjects in both arms of the study completed a fasting 43-blood chemistry panel and an 84-item self-reported quality of life inventory at baseline and again after participating in the study for six months. No significant differences were found in the within-group changes from baseline or between the groups on both sets of measures. | six months |