Back to resultsThe Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calcium Carbonate
Calcium Permeate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Subject is >50 years and <65 years of age by the time of inclusion.
- Subject has been menopausal for 2-5 years.
- Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
- Subject is non-smoking or able not to smoke during clinic visits.
- Subject with no history of osteoporotic fractures.
- 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.
- Subject with vitamin D insufficiency defined as ≤50nmol/l.
- Subject with an osteoporosis diagnosis.
- Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
- Subject with any serious illness e.g. cancer.
- Subject with lactose intolerance.
- Subject with celiac disease.
- Known or suspected abuse of alcohol or recreational drugs.
- Known or suspected hypersensitivity to trial products or related products.
- Subject where it is not possible to obtain sufficient data.
Sites / Locations
- Zealand University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Calcium Carbonate
Calcium-enriched permeate
Maltodextrin
Arm Description
800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.
800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.
0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.
Outcomes
Primary Outcome Measures
Serum Ionized calcium concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample will be collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Secondary Outcome Measures
Serum calcium concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Serum phosphate concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Serum magnesium concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Serum PTH concentration
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Urinary calcium concentration
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Urine phosphate concentration
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Urine magnesium concentration
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Full Information
NCT ID
NCT04550078
First Posted
August 10, 2020
Last Updated
November 16, 2020
Sponsor
Inge Tetens
Collaborators
Zealand University Hospital, Arla Foods, University of Aarhus, Innovation Fund Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04550078
Brief Title
The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study
Official Title
The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - A Randomized Controlled Cross-over Meal Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
November 6, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inge Tetens
Collaborators
Zealand University Hospital, Arla Foods, University of Aarhus, Innovation Fund Denmark
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
This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age 50-65 as subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium Carbonate
Arm Type
Active Comparator
Arm Description
800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.
Arm Title
Calcium-enriched permeate
Arm Type
Experimental
Arm Description
800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Carbonate
Intervention Description
Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Permeate
Other Intervention Name(s)
Capolac
Intervention Description
Subjects receive a single-dose of 800 mg milk calcium as calcium permeate provided in 6 capsules with a standardized breakfast served in the morning.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects receive a single-dose of 0 mg calcium as placebo with maltodextrin provided in 6 capsules with a standardized breakfast served in the morning.
Primary Outcome Measure Information:
Title
Serum Ionized calcium concentration
Description
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample will be collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Serum calcium concentration
Description
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Time Frame
3 months
Title
Serum phosphate concentration
Description
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Time Frame
3 months
Title
Serum magnesium concentration
Description
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Time Frame
3 months
Title
Serum PTH concentration
Description
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
Time Frame
3 months
Title
Urinary calcium concentration
Description
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Time Frame
3 months
Title
Urine phosphate concentration
Description
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Time Frame
3 months
Title
Urine magnesium concentration
Description
Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is >50 years and <65 years of age by the time of inclusion.
Subject has been menopausal for 2-5 years.
Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
Subject is non-smoking or able not to smoke during clinic visits.
Subject with no history of osteoporotic fractures.
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.
Subject with vitamin D insufficiency defined as ≤50nmol/l.
Subject with an osteoporosis diagnosis.
Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
Subject with any serious illness e.g. cancer.
Subject with lactose intolerance.
Subject with celiac disease.
Known or suspected abuse of alcohol or recreational drugs.
Known or suspected hypersensitivity to trial products or related products.
Subject where it is not possible to obtain sufficient data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Tetens, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study
We'll reach out to this number within 24 hrs