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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: Calcium Carbonate; Dietary Supplement: Calcium Permeate; Dietary Supplement: Placebo

• Registration Number: NCT04550078
• Lead Sponsor: Inge Tetens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-22
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Status Verified: 2020-11
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Calcium Carbonate	Calcium Carbonate	800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.
Calcium-enriched permeate	Calcium Permeate	800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.
Maltodextrin	Placebo	0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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 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).
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)

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Denmark