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

Inge Tetens

Status: Completed

Conditions: Osteoporosis

Treatments: Dietary Supplement: Calcium Permeate; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04550078

M235

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

10 participants in 3 patient groups, including a placebo group

Calcium Carbonate

Active Comparator group

Description:

800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.

Treatment:

Dietary Supplement: Calcium Carbonate

Calcium-enriched permeate

Experimental group

Description:

800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.

Treatment:

Dietary Supplement: Calcium Permeate

Maltodextrin

Placebo Comparator group

Description:

0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.

Treatment:

Dietary Supplement: Placebo