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ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDNA

ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial

NCT04836637•University of Copenhagen

View on ClinicalTrials.gov

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

Age

45 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

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.

Locations (2)

Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition

Copenhagen, Frederiksberg, Denmark

Zealand University Hospital

Køge, Denmark

Key Dates

Start Date

May 17, 2021

Primary Completion Date

July 4, 2023

Completion Date

July 4, 2023

Last Updated

October 6, 2023

Enrollment

420

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

Maltodextrin

DIETARY_SUPPLEMENT

Calcium-carbonate

DIETARY_SUPPLEMENT

Calcium-enriched permeate

DIETARY_SUPPLEMENT

Calcium-enriched permeate with Inulin

DIETARY_SUPPLEMENT

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

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RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

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WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects