Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D

NCT ID: NCT00663221

Last Updated: 2009-07-07

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

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

2

Group Type EXPERIMENTAL

Anthocyans, Calcium and Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Anthocyans, Calcium and Vitamin D

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Women
* Aged between 50 and 65 years
* Between 1 and 5 years menopause
* IMC between 19 and 30 kg/m²

Exclusion Criteria

* Medical Treatment for bone metabolism
* Vitamin D not including in the range of 20nmoles\<25(OH)\<100nmoles/l
* Vegan and vegetarian diet
* Regular consumption of food supplementary benefits
* Lactose intolerance
* While dieting
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

Elvir SAS

INDUSTRY

Sponsor Role lead

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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LC2 Atlas

Identifier Type: -

Identifier Source: org_study_id

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