ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women (RENEW)

University of Copenhagen

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Dietary Supplement: Calcium-enriched permeate; Dietary Supplement: Calcium-carbonate; Dietary Supplement: Maltodextrin; Dietary Supplement: Calcium-enriched permeate with Inulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04836637

M236

Details and patient eligibility

About

The primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.

Full description

The study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial products. Outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters will moreover be analyzed based on DXA scan obtained at the randomization visit and at the final visit at 12 months.

Enrollment: 420 patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is between 45 years and 65 years of age by the time of inclusion.
• Subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years.
• Subject is Caucasian.
• Has a BMI below 35.0.
• Holder of a computer.
• Has a sufficient vitamin D status (plasma 25OHD concentration > 50 nmol/L).
• 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 evaluated by the investigator.
• Intake of antibiotics in the last 3 months before enrollment.
• Subject with an osteoporosis diagnosis or history of osteoporotic fractures.
• Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
• Subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer).
• Known or suspected abuse of alcohol or recreational drugs.
• Known milk allergy.
• Known or suspected hypersensitivity to trial products or related products.
• Blood donation except from the donation in this study.
• Subject where it is not possible to obtain sufficient data.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

420 participants in 4 patient groups, including a placebo group

Product with placebo (no calcium supplementation).

Placebo Comparator group

Description:

Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year.

Treatment:

Dietary Supplement: Maltodextrin

Product with calcium-carbonate

Active Comparator group

Description:

800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year.

Treatment:

Dietary Supplement: Calcium-carbonate

Product with calcium-enriched permeate "Capolac"

Experimental group

Description:

800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year.

Treatment:

Dietary Supplement: Calcium-enriched permeate

Product with calcium-enriched permeate "Capolac" and Inulin

Experimental group

Description:

800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year.

Treatment:

Dietary Supplement: Calcium-enriched permeate with Inulin