Osteoporosis, PostmenopausalRENEWNCT04836637
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women
A study testing Maltodextrin, Calcium-carbonate and Calcium-enriched permeate in people with Osteoporosis, Postmenopausal, run by University of Copenhagen at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Maltodextrin, Calcium-carbonate and Calcium-enriched permeate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 2 sitesDenmark
- Study dates
- 17 May 2021to 4 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition
Copenhagen, Frederiksberg
Zealand University Hospital
Køge, 4600
About this study
Official title: ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial
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.
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Maltodextrin, Calcium-carbonate, Calcium-enriched permeate, Calcium-enriched permeate with Inulin
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaltodextrinDietary supplement
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-carbonateDietary supplement
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 permeateDietary supplement
Also called Capolac
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 InulinDietary supplement
Also called Capolac 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.
| Study group | Role | What they receive |
|---|---|---|
| Product with placebo (no calcium supplementation). | Placebo comparator | Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year. Receives: Dietary Supplement: Maltodextrin |
| Product with calcium-carbonate | Active comparator | 800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year. Receives: Dietary Supplement: Calcium-carbonate |
| Product with calcium-enriched permeate "Capolac" | Experimental | 800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year. Receives: Dietary Supplement: Calcium-enriched permeate |
| Product with calcium-enriched permeate "Capolac" and Inulin | Experimental | 800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year. Receives: Dietary Supplement: Calcium-enriched permeate with Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in bone turnover marker CTX.
Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit)
Measured: 1 year
The change in bone turnover marker P1NP.
Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit)
Measured: 1 year
The change in loss of bone mineral density.
Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit)
Measured: 1 year
Secondary outcomes (4)
Changes in blood parameters of iPTH
Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)
Measured: 1 year
Changes in blood parameters of Vitamin D
Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)
Measured: 1 year
Changes in blood parameters of total calcium
Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)
Measured: 1 year
Changes in blood parameters of phosphate
Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start17 May 2021
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Responsible party
- Principal investigator, Inge Tetens, University of Copenhagen
- Investigators
- Mette F Hitz, Doctor, Principal investigator, Zealand University Hospital, Køge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836637
- Sponsor's protocol ID
- M236
- Acronym
- RENEW
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be analyzed and attempted published in international journals regardsless of whether the study leads to positive, negative or inconclusive results. The study protocol will be registered and made publicly avalailable at www.clinicaltrials.gov.
Publications
Tetens I, Kisi SB, Parlesak A, Rasmussen SI, Cramon MO, Petersen CF, Lemay DG, Nielsen DS, Bertram HC, Andersen HJ, Hitz MF. Effects of a 1-year calcium-enriched permeate supplement on bone health in postmenopausal females: The RENEW randomized controlled intervention trial. Am J Clin Nutr. 2026 Jul;124(1):101339. doi: 10.1016/j.ajcnut.2026.101339. Epub 2026 May 6.
PubMed 42097280
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial
- ClinicalTrials.gov ID
- NCT04836637
- Acronym / sponsor ID
- RENEW / M236
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- 17 May 2021 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Product with placebo (no calcium supplementation). | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year. |
| Product with calcium-carbonate | Active comparator | Dietary Supplement: Calcium-carbonate800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year. |
| Product with calcium-enriched permeate "Capolac" | Experimental | Dietary Supplement: Calcium-enriched permeate800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year. |
| Product with calcium-enriched permeate "Capolac" and Inulin | Experimental | Dietary Supplement: Calcium-enriched permeate with Inulin800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaltodextrinThree 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 | Product with placebo (no calcium supplementation). |
| Calcium-carbonateThree 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 | Product with calcium-carbonate |
| Calcium-enriched permeateAlso: CapolacThree 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 | Product with calcium-enriched permeate "Capolac" |
| Calcium-enriched permeate with InulinAlso: Capolac InulinThree 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 | Product with calcium-enriched permeate "Capolac" and Inulin |
Primary outcome
The change in bone turnover marker CTX.
Time frame: 1 year
Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit)
The change in bone turnover marker P1NP.
Time frame: 1 year
Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit)
The change in loss of bone mineral density.
Time frame: 1 year
Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit)
4 secondary outcomes
Changes in blood parameters of iPTH
Time frame: 1 year
Changes in blood parameters of Vitamin D
Time frame: 1 year
Changes in blood parameters of total calcium
Time frame: 1 year
Changes in blood parameters of phosphate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 42097280Tetens I, Kisi SB, Parlesak A, Rasmussen SI, Cramon MO, Petersen CF, Lemay DG, Nielsen DS, Bertram HC, Andersen HJ, Hitz MF. Effects of a 1-year calcium-enriched permeate supplement on bone health in postmenopausal females: The RENEW randomized controlled intervention trial. Am J Clin Nutr. 2026 Jul;124(1):101339. doi: 10.1016/j.ajcnut.2026.101339. Epub 2026 May 6.
- Individual participant dataSharing planned: No. The results will be analyzed and attempted published in international journals regardsless of whether the study leads to positive, negative or inconclusive results. The study protocol will be registered and made publicly avalailable at www.clinicaltrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette F Hitz, Doctor principal investigator
Zealand University Hospital, Køge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin, Calcium-carbonate and Calcium-enriched permeate in people with Osteoporosis, Postmenopausal, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in bone turnover marker CTX. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.