Osteopenia
Conditions
Brief summary
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.
Detailed description
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. 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.
Interventions
DIETARY_SUPPLEMENTAlgaeCal-1
Daily consumption of 7 capsules containing bone health ingredients
DIETARY_SUPPLEMENTAlgaeCal-2
Taking 7 capsules a day for six months
Sponsors
AlgaeCal Inc.
Integrative Health Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Bone Mineral Density (BMD) | baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups | six months | 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. |
Countries
United States
Outcome results
None listed