ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    400
  • sponsor
    University of Copenhagen
Updated on 22 May 2021
calcium
vitamin d

Summary

The primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.

Description

The study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial products. Outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters will moreover be analyzed based on DXA scan obtained at the randomization visit and at the final visit at 12 months.

Details
Condition Postmenopausal osteoporosis
Treatment Maltodextrin, Calcium-carbonate, Calcium-enriched permeate, Calcium-enriched permeate with Inulin
Clinical Study IdentifierNCT04836637
SponsorUniversity of Copenhagen
Last Modified on22 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is between 45 years and 65 years of age by the time of inclusion
Subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years
Subject is Caucasian
Has a BMI below 35.0
Holder of a computer
Has a sufficient vitamin D status (plasma 25OHD concentration > 50 nmol/L)
Subject is willing and able to provide written informed consent prior to participation

Exclusion Criteria

Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy evaluated by the investigator
Intake of antibiotics in the last 3 months before enrollment
Subject with an osteoporosis diagnosis or history of osteoporotic fractures
Presence of renal, gastrointestinal, hepatic or endocrinological diseases
Subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
Known or suspected abuse of alcohol or recreational drugs
Known milk allergy
Known or suspected hypersensitivity to trial products or related products
Blood donation except from the donation in this study
Subject where it is not possible to obtain sufficient data
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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