NCT04550078 - The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

10

Conditions

Osteoporosis

Interventions

Calcium CarbonateDIETARY_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.

Calcium PermeateDIETARY_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.

PlaceboDIETARY_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.

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Zealand University Hospital

Køge, Denmark

Outcomes

Primary Outcomes

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).

Time frame: 3 months

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 3 months