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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Dietary supplement: Calcium Carbonate; Dietary supplement: Calcium Permeate; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Calcium Carbonate; 800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.	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.
EXPERIMENTAL: Calcium-enriched permeate; 800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.	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.; Other Names: Capolac
PLACEBO_COMPARATOR: Maltodextrin; 0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Inge Tetens
• Collaborators: Zealand University Hospital; University of Aarhus; Innovation Fund Denmark; Arla Foods
• Investigators: Principal Investigator: Inge Tetens, Professor, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2020
• Primary Completion (ACTUAL): November 6, 2020
• Study Completion (ACTUAL): November 6, 2020

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium, Dietary; Calcium Carbonate
• Other Study ID Numbers: M235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No