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

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.

Full Title of Study: “The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate – A Randomized Controlled Cross-over Meal Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 30, 2020

Interventions

  • 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.
  • Dietary Supplement: 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.
  • Dietary Supplement: 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.

Arms, Groups and Cohorts

  • Active Comparator: Calcium Carbonate
    • 800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.
  • Experimental: Calcium-enriched permeate
    • 800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.
  • Placebo Comparator: Maltodextrin
    • 0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).
  • 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).
  • 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).
  • 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).
  • 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)
  • 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)
  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Inge Tetens
  • Collaborator
    • Zealand University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Inge Tetens, Professor – University of Copenhagen
  • Overall Official(s)
    • Inge Tetens, Professor, Principal Investigator, University of Copenhagen
  • Overall Contact(s)
    • Inge Tetens, Professor, 004535332127, ite@nexs.ku.dk

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.