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NCT Number: NCT04550078

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

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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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University Hospital

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Other names: Capolac

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.

Primary outcomes

  1. Serum Ionized calcium concentration

    Time frame: 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 outcomes

  1. Serum calcium concentration

    Time frame: 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).

  2. Serum phosphate concentration

    Time frame: 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).

  3. Serum magnesium concentration

    Time frame: 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).

  4. Serum PTH concentration

    Time frame: 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).

  5. Urinary calcium concentration

    Time frame: 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)

  6. Urine phosphate concentration

    Time frame: 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)

  7. Urine magnesium concentration

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Inge Tetens

Other

Collaborators

  • Arla Foods
  • Innovation Fund Denmark
  • University of Aarhus
  • Zealand University Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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