Clinical trial NCT04836637: ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women
Official title: ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2021-04-08
Enrollment: 420
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in bone turnover marker CTX.
timeFrame: 1 year
measure: The change in bone turnover marker P1NP.
timeFrame: 1 year
measure: The change in loss of bone mineral density.
timeFrame: 1 year
Secondary outcomes:
measure: Changes in blood parameters of iPTH
timeFrame: 1 year
measure: Changes in blood parameters of Vitamin D
timeFrame: 1 year
measure: Changes in blood parameters of total calcium
timeFrame: 1 year
measure: Changes in blood parameters of phosphate
timeFrame: 1 year
Other outcomes:
measure: Changes in BMI
timeFrame: 1 year
measure: Changes in physical activity
timeFrame: 1 year
measure: Changes in habitual dietary intake
timeFrame: 1 year
measure: Changes in fecal pH
timeFrame: 1 year
measure: Changes in gut microbiome
timeFrame: 1 year
measure: Changes in urinary metabolites
timeFrame: 1 year
measure: Changes in fecal metabolites
timeFrame: 1 year
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition
state: Frederiksberg
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital, Køge
name: Mette F Hitz, Doctor
role: PRINCIPAL_INVESTIGATOR
References: