ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women
NCT ID: NCT04836637
Last Updated: 2023-10-06
Study Results
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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COMPLETED
NA
420 participants
INTERVENTIONAL
2021-05-17
2023-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Product with placebo (no calcium supplementation).
Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year.
Maltodextrin
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Product with calcium-carbonate
800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year.
Calcium-carbonate
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Product with calcium-enriched permeate "Capolac"
800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year.
Calcium-enriched permeate
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Product with calcium-enriched permeate "Capolac" and Inulin
800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year.
Calcium-enriched permeate with Inulin
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Interventions
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Maltodextrin
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Calcium-carbonate
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Calcium-enriched permeate
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Calcium-enriched permeate with Inulin
Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
75 Years
FEMALE
Yes
Sponsors
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Zealand University Hospital
OTHER
University of Copenhagen
OTHER
Responsible Party
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Inge Tetens
Professor
Principal Investigators
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Mette F Hitz, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital, Køge
Locations
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Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition
Copenhagen, Frederiksberg, Denmark
Zealand University Hospital
Køge, , Denmark
Countries
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Other Identifiers
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M236
Identifier Type: -
Identifier Source: org_study_id
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