ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women (RENEW)

October 5, 2023 updated by: Inge Tetens, University of Copenhagen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Zealand University Hospital
    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark
        • Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Product with placebo (no calcium supplementation).
Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year.
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.
Active Comparator: Product with calcium-carbonate
800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year.
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.
Experimental: Product with calcium-enriched permeate "Capolac"
800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year.
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.
Other Names:
  • Capolac
Experimental: Product with calcium-enriched permeate "Capolac" and Inulin
800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year.
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.
Other Names:
  • Capolac Inulin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
1 year
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)
1 year
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)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in blood parameters of iPTH
Time Frame: 1 year
Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)
1 year
Changes in blood parameters of Vitamin D
Time Frame: 1 year
Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)
1 year
Changes in blood parameters of total calcium
Time Frame: 1 year
Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)
1 year
Changes in blood parameters of phosphate
Time Frame: 1 year
Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in BMI
Time Frame: 1 year
Changes in BMI from randomization to 12 months visit (final visit)
1 year
Changes in physical activity
Time Frame: 1 year
Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit)
1 year
Changes in habitual dietary intake
Time Frame: 1 year
Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit)
1 year
Changes in fecal pH
Time Frame: 1 year
Changes in fecal pH from randomization to 12 months visit (final visit)
1 year
Changes in gut microbiome
Time Frame: 1 year
Changes in microbial taxonomy and microbial gene content measured via sequencing of DNA extracted from fecal samples from randomization to 12 months visit (final visit)
1 year
Changes in urinary metabolites
Time Frame: 1 year
Changes in urine metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatinine, amines, amino acids, alcohols, carboxylic acids including short-chain fatty acids, keto acids, purine, pyridine and pyrimidine derivatives, sugars and derivatives.
1 year
Changes in fecal metabolites
Time Frame: 1 year
Changes in fecal metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatine, creatinine, amines, amino acids, carboxylic acids including short-chain fatty acids, keto acids, nucleotides and derivatives.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zealand University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mette F Hitz, Doctor, Zealand University Hospital, Køge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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