Status:
COMPLETED
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Zealand University Hospital
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
45-75 years
Phase:
NA
Brief 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 ...
Detailed 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 parame...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2023
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04836637
Start Date
May 17 2021
End Date
July 4 2023
Last Update
October 6 2023
Active Locations (2)
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1
Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition
Copenhagen, Frederiksberg, Denmark
2
Zealand University Hospital
Køge, Denmark, 4600