Back to resultsValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women (RENEW)
Primary Purpose
Osteoporosis, Postmenopausal
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Maltodextrin
Calcium-carbonate
Calcium-enriched permeate
Calcium-enriched permeate with Inulin
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis, Postmenopausal
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.
Sites / Locations
- Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition
- Zealand University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Experimental
Experimental
Arm Label
Product with placebo (no calcium supplementation).
Product with calcium-carbonate
Product with calcium-enriched permeate "Capolac"
Product with calcium-enriched permeate "Capolac" and Inulin
Arm Description
Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year.
800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year.
800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year.
800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year.
Outcomes
Primary Outcome Measures
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)
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)
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)
Secondary Outcome Measures
Changes in blood parameters of iPTH
Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)
Changes in blood parameters of Vitamin D
Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)
Changes in blood parameters of total calcium
Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)
Changes in blood parameters of phosphate
Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)
Full Information
NCT ID
NCT04836637
First Posted
March 30, 2021
Last Updated
October 5, 2023
Sponsor
University of Copenhagen
Collaborators
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04836637
Brief Title
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women
Acronym
RENEW
Official Title
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
July 4, 2023 (Actual)
Study Completion Date
July 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Zealand University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Product with placebo (no calcium supplementation).
Arm Type
Placebo Comparator
Arm Description
Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year.
Arm Title
Product with calcium-carbonate
Arm Type
Active Comparator
Arm Description
800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year.
Arm Title
Product with calcium-enriched permeate "Capolac"
Arm Type
Experimental
Arm Description
800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year.
Arm Title
Product with calcium-enriched permeate "Capolac" and Inulin
Arm Type
Experimental
Arm Description
800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium-carbonate
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium-enriched permeate
Other Intervention Name(s)
Capolac
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium-enriched permeate with Inulin
Other Intervention Name(s)
Capolac Inulin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in bone turnover marker CTX.
Description
Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit)
Time Frame
1 year
Title
The change in bone turnover marker P1NP.
Description
Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit)
Time Frame
1 year
Title
The change in loss of bone mineral density.
Description
Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in blood parameters of iPTH
Description
Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)
Time Frame
1 year
Title
Changes in blood parameters of Vitamin D
Description
Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)
Time Frame
1 year
Title
Changes in blood parameters of total calcium
Description
Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)
Time Frame
1 year
Title
Changes in blood parameters of phosphate
Description
Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Changes in BMI
Description
Changes in BMI from randomization to 12 months visit (final visit)
Time Frame
1 year
Title
Changes in physical activity
Description
Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit)
Time Frame
1 year
Title
Changes in habitual dietary intake
Description
Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit)
Time Frame
1 year
Title
Changes in fecal pH
Description
Changes in fecal pH from randomization to 12 months visit (final visit)
Time Frame
1 year
Title
Changes in gut microbiome
Description
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)
Time Frame
1 year
Title
Changes in urinary metabolites
Description
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.
Time Frame
1 year
Title
Changes in fecal metabolites
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette F Hitz, Doctor
Organizational Affiliation
Zealand University Hospital, Køge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition
City
Copenhagen
State/Province
Frederiksberg
Country
Denmark
Facility Name
Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women
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