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Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
CaCO3
Kefir
Sponsored by
Ministry of Science and Technology, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of osteoporosis patients

Exclusion Criteria:

  • Any previous use of parathyroid hormone or sodium fluoride, use of anabolic steroids or growth hormone within 6 months before trial entry or oral or intravenous systemic corticosteroids within 12 months, and any previous use of strontium.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Kefir and CaCO3

    Placebo and CaCO3

    Arm Description

    Kefir were administered 1,600 mg kefir-fermented milk per day and an accompanying supplement of 1,500 mg CaCO3 for 6 months

    Placebo and 1,500 mg of CaCO3 daily for 6 months

    Outcomes

    Primary Outcome Measures

    bone mineral density and bone regeneration

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2014
    Last Updated
    August 30, 2015
    Sponsor
    Ministry of Science and Technology, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02361372
    Brief Title
    Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
    Official Title
    Short-term Effect of Kefir-fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ministry of Science and Technology, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In a controlled, parallel, double-blind intervention study over 6 months, the investigators investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA) at baseline and at 6 months.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kefir and CaCO3
    Arm Type
    Experimental
    Arm Description
    Kefir were administered 1,600 mg kefir-fermented milk per day and an accompanying supplement of 1,500 mg CaCO3 for 6 months
    Arm Title
    Placebo and CaCO3
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo and 1,500 mg of CaCO3 daily for 6 months
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo daily for 6 months
    Intervention Type
    Other
    Intervention Name(s)
    CaCO3
    Intervention Description
    CaCO3 daily for 6 months
    Intervention Type
    Other
    Intervention Name(s)
    Kefir
    Intervention Description
    Kefir daily for 6 months
    Primary Outcome Measure Information:
    Title
    bone mineral density and bone regeneration
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of osteoporosis patients Exclusion Criteria: Any previous use of parathyroid hormone or sodium fluoride, use of anabolic steroids or growth hormone within 6 months before trial entry or oral or intravenous systemic corticosteroids within 12 months, and any previous use of strontium.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26655888
    Citation
    Tu MY, Chen HL, Tung YT, Kao CC, Hu FC, Chen CM. Short-Term Effects of Kefir-Fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in a Randomized Clinical Trial of Osteoporotic Patients. PLoS One. 2015 Dec 10;10(12):e0144231. doi: 10.1371/journal.pone.0144231. eCollection 2015.
    Results Reference
    derived

    Learn more about this trial

    Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

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