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

NCT ID: NCT01114685

Last Updated: 2010-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-03-31

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:

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.

Conditions

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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Effects of taking AlgaeCal-1

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

Group Type ACTIVE_COMPARATOR

AlgaeCal-1

Intervention Type DIETARY_SUPPLEMENT

Daily consumption of 7 capsules containing bone health ingredients

Effects of taking AlgaeCal-2

Following a bone-health plan while consuming AlgaeCal 2

Group Type ACTIVE_COMPARATOR

AlgaeCal-2

Intervention Type DIETARY_SUPPLEMENT

Taking 7 capsules a day for six months

Interventions

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AlgaeCal-1

Daily consumption of 7 capsules containing bone health ingredients

Intervention Type DIETARY_SUPPLEMENT

AlgaeCal-2

Taking 7 capsules a day for six months

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AlgaeCal Inc.

INDUSTRY

Sponsor Role collaborator

Integrative Health Technologies, Inc.

NETWORK

Sponsor Role lead

Responsible Party

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Integrative Health Technologies, Inc.

Principal Investigators

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Gilbert R Kaats, PhD

Role: PRINCIPAL_INVESTIGATOR

Integrative Health Technologies

Harry G Preuss, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Integrative Health Technologies

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21492428 (View on PubMed)

Other Identifiers

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AlgaeCal 1 & 2

Identifier Type: -

Identifier Source: org_study_id

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