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| Name | Class |
|---|---|
| Zealand University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product with placebo (no calcium supplementation). | Placebo Comparator | Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year. |
|
| Product with calcium-carbonate | Active Comparator | 800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year. |
|
| Product with calcium-enriched permeate "Capolac" | Experimental | 800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year. |
|
| Product with calcium-enriched permeate "Capolac" and Inulin | Experimental | 800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maltodextrin | Dietary Supplement | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in BMI | Changes in BMI from randomization to 12 months visit (final visit) | 1 year |
| Changes in physical activity | Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette F Hitz, Doctor | Zealand University Hospital, Køge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition | Copenhagen | Frederiksberg | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42097280 | Derived | Tetens I, Kisi SB, Parlesak A, Rasmussen SI, Cramon MO, Petersen CF, Lemay DG, Nielsen DS, Bertram HC, Andersen HJ, Hitz MF. Effects of a 1-year calcium-enriched permeate supplement on bone health in postmenopausal females: The RENEW randomized controlled intervention trial. Am J Clin Nutr. 2026 Jul;124(1):101339. doi: 10.1016/j.ajcnut.2026.101339. Epub 2026 May 6. |
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The results will be analyzed and attempted published in international journals regardsless of whether the study leads to positive, negative or inconclusive results. The study protocol will be registered and made publicly avalailable at www.clinicaltrials.gov.
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D002119 | Calcium Carbonate |
| D007444 | Inulin |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Calcium-carbonate | Dietary Supplement | 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. |
|
| Calcium-enriched permeate | Dietary Supplement | 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. |
|
|
| Calcium-enriched permeate with Inulin | Dietary Supplement | 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. |
|
|
| 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 |
| 1 year |
| Changes in habitual dietary intake | Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit) | 1 year |
| Changes in fecal pH | Changes in fecal pH from randomization to 12 months visit (final visit) | 1 year |
| Changes in gut microbiome | Changes in microbial taxonomy and microbial gene content measured via sequencing of DNA extracted from fecal samples from randomization to 12 months visit (final visit) | 1 year |
| Changes in urinary metabolites | Changes in urine metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatinine, amines, amino acids, alcohols, carboxylic acids including short-chain fatty acids, keto acids, purine, pyridine and pyrimidine derivatives, sugars and derivatives. | 1 year |
| Changes in fecal metabolites | Changes in fecal metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatine, creatinine, amines, amino acids, carboxylic acids including short-chain fatty acids, keto acids, nucleotides and derivatives. | 1 year |
| Zealand University Hospital | Køge | 4600 | Denmark |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |