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Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
yogurt
Sponsored by
Universidad de la Republica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring functional foods, dairy foods, calcium absorption, prebiotics and probiotics, young women, bone health

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ages 18 to 35 years
  • generally healthy

Exclusion Criteria:

  • pregnancy/lactation
  • BMI <18,5 kg/m2
  • BMI> 29 kg/m2
  • metabolic disorders, bone, liver or kidney disease that may affect calcium metabolism
  • smoking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    functional yogurt

    control yogurt

    Arm Description

    Participants are given the symbiotic yogurt daily (180 ml)

    Participants are given the control yogurt daily (180 ml)

    Outcomes

    Primary Outcome Measures

    Change in calcium absorption
    Fractional calcium absorption measured with stable isotopes

    Secondary Outcome Measures

    Serum 25(OH) vitamin D
    Serum 25 (OH) vitamin D values expressed in nmol/liter
    Bone mineral content and bone mineral density
    Bone mineral content and bone mineral density values expressed as Z scores.
    Dietary calcium intake
    Values expressed in mg/d

    Full Information

    First Posted
    January 12, 2018
    Last Updated
    February 1, 2018
    Sponsor
    Universidad de la Republica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03420716
    Brief Title
    Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
    Official Title
    Effect of Regular Consumption of a Symbiotic Yogurt on Calcium Absorption and Bone Health in Young Adult Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de la Republica

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prebiotics have been linked to increased calcium absorption in animal and human studies (particularly in adolescents and in premenopausal women). Similarly, probiotics have been found to benefit calcium homeostasis in pregnant women, and to promote bio-mineralization in animal models. The effect of symbiotic on calcium absorption has been tested in rats, but not in human studies. The primary objective of this study is to investigate the effect of daily consumption of a functional symbiotic yogurt containing inulin and Lactobacillus rhamnosus compared to a control yogurt, on calcium absorption in young adult women. A secondary objective is to relate changes in calcium absorption following yogurt consumption, with calcium metabolism, vitamin D status, bone mass, calcium intake and overall composition of habitual diet.
    Detailed Description
    A potential strategy to reduce the risk of osteoporosis later in life is to promote optimal bone mass during early adulthood by including in the diet functional foods that maximize the efficiency of calcium absorption. This approach is specially important in women because of their greater risk for osteoporosis than men. In this study, we hypothesized that the daily consumption of a yogurt containing inulin and Lactobacillus rhamnosus (symbiotic yogurt) increases the efficiency of calcium absorption in young adult women when compared to daily consumption of a yogurt of similar composition but without prebiotic or probiotic (control yogurt). Subjects in this study will be randomly assigned to consume daily the symbiotic yogurt or the control yogurt during two 3-week periods with a wash-out period of 3-weeks, in a cross-over design. Calcium absorption will be measured by stable calcium isotope methodology. Bone mass (BMD, BMC) will be measured by dual-Y ray absorptiometry. Serum intact parathyroid hormone, 25-hydroxyvitamin D and dietary intake will be measured by conventional methods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    functional foods, dairy foods, calcium absorption, prebiotics and probiotics, young women, bone health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    3 weeks on symbiotic yogurt or control yogurt, with a 3 week wash out period in between. Type of yougurt consumed first is randomized.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Type of yogurt fed is blind for participants and investigators
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    functional yogurt
    Arm Type
    Experimental
    Arm Description
    Participants are given the symbiotic yogurt daily (180 ml)
    Arm Title
    control yogurt
    Arm Type
    Experimental
    Arm Description
    Participants are given the control yogurt daily (180 ml)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    yogurt
    Primary Outcome Measure Information:
    Title
    Change in calcium absorption
    Description
    Fractional calcium absorption measured with stable isotopes
    Time Frame
    Day 21 and Day 63
    Secondary Outcome Measure Information:
    Title
    Serum 25(OH) vitamin D
    Description
    Serum 25 (OH) vitamin D values expressed in nmol/liter
    Time Frame
    Day 1
    Title
    Bone mineral content and bone mineral density
    Description
    Bone mineral content and bone mineral density values expressed as Z scores.
    Time Frame
    Day 1
    Title
    Dietary calcium intake
    Description
    Values expressed in mg/d
    Time Frame
    Day 1

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ages 18 to 35 years generally healthy Exclusion Criteria: pregnancy/lactation BMI <18,5 kg/m2 BMI> 29 kg/m2 metabolic disorders, bone, liver or kidney disease that may affect calcium metabolism smoking

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35411924
    Citation
    Cornes R, Sintes C, Pena A, Albin S, O'Brien KO, Abrams SA, Donangelo CM. Daily Intake of a Functional Synbiotic Yogurt Increases Calcium Absorption in Young Adult Women. J Nutr. 2022 Jul 6;152(7):1647-1654. doi: 10.1093/jn/nxac088.
    Results Reference
    derived

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    Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women

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