ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

Not Applicable

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Dietary Supplement: Calcium-enriched permeate; Dietary Supplement: Maltodextrin; Dietary Supplement: Calcium-carbonate; Dietary Supplement: Calcium-enriched permeate with Inulin

• Registration Number: NCT04836637
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Study Start: 2021-05-17
• Primary Completion: 2023-07-04
• Study Completion: 2023-07-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Product with calcium-enriched permeate "Capolac"	Calcium-enriched permeate	800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year.
Product with placebo (no calcium supplementation).	Maltodextrin	Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year.
Product with calcium-carbonate	Calcium-carbonate	800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year.
Product with calcium-enriched permeate "Capolac" and Inulin	Calcium-enriched permeate with Inulin	800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year.

Primary Outcome Measures

Name	Time	Method
The change in bone turnover marker CTX.	1 year	Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit)
The change in bone turnover marker P1NP.	1 year	Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit)
The change in loss of bone mineral density.	1 year	Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit)

Secondary Outcome Measures

Name	Time	Method
Changes in blood parameters of iPTH	1 year	Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)
Changes in blood parameters of Vitamin D	1 year	Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)
Changes in blood parameters of phosphate	1 year	Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)
Changes in blood parameters of total calcium	1 year	Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)

Trial Locations

Locations (2)

Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition; 🇩🇰 Copenhagen, Frederiksberg, Denmark

Zealand University Hospital; 🇩🇰 Køge, Denmark