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| Name | Class |
|---|---|
| Zealand University Hospital | OTHER |
| Arla Foods | INDUSTRY |
| University of Aarhus | OTHER |
| Innovation Fund Denmark |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Carbonate | Active Comparator | 800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal. |
|
| Calcium-enriched permeate | Experimental | 800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal. |
|
| Maltodextrin | Placebo Comparator | 0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Carbonate | Dietary Supplement | Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inge Tetens, Professor | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Køge | 4600 | Denmark |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| INDIV |
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Double-blinded
| Calcium Permeate | Dietary Supplement | 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. |
|
|
| Placebo | Dietary Supplement | 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. |
|
| 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). |
| 3 months |
| 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). | 3 months |
| 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). | 3 months |
| 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) | 3 months |
| 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) | 3 months |
| 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) | 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |