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

Primary Purpose

Osteopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AlgaeCal-1
AlgaeCal-2
Sponsored by
Integrative Health Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Integrative Health Technologies

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Effects of taking AlgaeCal-1

Effects of taking AlgaeCal-2

Arm Description

Following a bone health plan with Algae-cal-1 supplement

Following a bone-health plan while consuming AlgaeCal 2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 19, 2010
Last Updated
April 30, 2010
Sponsor
Integrative Health Technologies, Inc.
Collaborators
AlgaeCal Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01114685
Brief Title
A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements
Official Title
Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Integrative Health Technologies, Inc.
Collaborators
AlgaeCal Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effects of taking AlgaeCal-1
Arm Type
Active Comparator
Arm Description
Following a bone health plan with Algae-cal-1 supplement
Arm Title
Effects of taking AlgaeCal-2
Arm Type
Active Comparator
Arm Description
Following a bone-health plan while consuming AlgaeCal 2
Intervention Type
Dietary Supplement
Intervention Name(s)
AlgaeCal-1
Intervention Description
Daily consumption of 7 capsules containing bone health ingredients
Intervention Type
Dietary Supplement
Intervention Name(s)
AlgaeCal-2
Intervention Description
Taking 7 capsules a day for six months
Primary Outcome Measure Information:
Title
Changes in Bone Mineral Density (BMD)
Description
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.
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups
Description
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.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert R Kaats, PhD
Organizational Affiliation
Integrative Health Technologies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry G Preuss, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Health Technologies
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21492428
Citation
Michalek JE, Preuss HG, Croft HA, Keith PL, Keith SC, Dapilmoto M, Perricone NV, Leckie RB, Kaats GR. 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. Nutr J. 2011 Apr 14;10:32. doi: 10.1186/1475-2891-10-32.
Results Reference
derived

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

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