ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Dietary Supplement: Maltodextrin
* Dietary Supplement: Calcium-carbonate
* Dietary Supplement: Calcium-enriched permeate
* Dietary Supplement: Calcium-enriched permeate with Inulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Product with placebo (no calcium supplementation).<br>Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year. | Dietary Supplement: Maltodextrin<br>* Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.<br>|
| Active Comparator: Product with calcium-carbonate<br>800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year. | Dietary Supplement: Calcium-carbonate<br>* Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.<br>|
| Experimental: Product with calcium-enriched permeate Capolac<br>800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year. | Dietary Supplement: Calcium-enriched permeate<br>* Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.<br>* Other names: Capolac;|
| Experimental: Product with calcium-enriched permeate Capolac and Inulin<br>800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year. | Dietary Supplement: Calcium-enriched permeate with Inulin<br>* Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.<br>* Other names: Capolac Inulin;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood parameters of iPTH | Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit) | 1 year | 
| Changes in blood parameters of Vitamin D | Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit) | 1 year | 
| Changes in blood parameters of total calcium | Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit) | 1 year | 
| Changes in blood parameters of phosphate | Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit) | 1 year |