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

Not Applicable

Completed

• Conditions: Osteopenia
• Interventions: Dietary Supplement: AlgaeCal-2; Dietary Supplement: AlgaeCal-1

• Registration Number: NCT01114685
• Lead Sponsor: Integrative Health Technologies, Inc.

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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-07
• Study Completion: 2010-03
• Status Verified: 2010-04
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-30
• Last Update Submitted: 2010-04-30
• Study First Posted: 2010-05-03
• Last Update Posted: 2010-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Effects of taking AlgaeCal-2	AlgaeCal-2	Following a bone-health plan while consuming AlgaeCal 2
Effects of taking AlgaeCal-1	AlgaeCal-1	Following a bone health plan with Algae-cal-1 supplement

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Integrative Health Technologies; 🇺🇸 San Antonio, Texas, United States