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ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

NCT04836637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Zealand University Hospital

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Mette F Hitz, Doctor · Zealand University Hospital, Køge

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2023-07-04
Completion
2023-07-04

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836637 on ClinicalTrials.gov