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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550078
• Other study ID #: M235
• Status: Completed
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: November 6, 2020

Study information

• Verified date: November 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• Calcium 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.
• Calcium 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.
• Placebo
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.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge

Sponsors (5)

Lead Sponsor	Collaborator
Inge Tetens	Arla Foods, Innovation Fund Denmark, University of Aarhus, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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