The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study

Study Overview
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Brief Summary
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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.

Official Title
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The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - A Randomized Controlled Cross-over Meal Study

Conditions
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Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Calcium Carbonate
* Dietary Supplement: Calcium Permeate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium Carbonate<br>800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal. | Dietary Supplement: Calcium Carbonate<br>* Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.<br>|
| Experimental: Calcium-enriched permeate<br>800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal. | Dietary Supplement: Calcium Permeate<br>* 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.<br>* Other names: Capolac;|
| Placebo Comparator: Maltodextrin<br>0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |