Osteoporosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCalcium Carbonate
Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.
DIETARY_SUPPLEMENTCalcium Permeate
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Zealand University Hospital
Arla Foods
University of Aarhus
Innovation Fund Denmark
Inge Tetens
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Ionized calcium concentration | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Urine phosphate concentration | 3 months | 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) |
| Serum calcium concentration | 3 months | 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 | 3 months | 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 | 3 months | 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) |
| Serum PTH concentration | 3 months | 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). |
| Urine magnesium concentration | 3 months | 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) |
| Serum magnesium concentration | 3 months | 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). |
Countries
Denmark
Outcome results
None listed