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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
420
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.
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.
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.
Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition
Copenhagen, Frederiksberg, Denmark
Zealand University Hospital
Køge, Denmark
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)
Time frame: 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)
Time frame: 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)
Time frame: 1 year
Changes in blood parameters of iPTH
Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)
Time frame: 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)
Time frame: 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)
Time frame: 1 year
Changes in blood parameters of phosphate
Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)
Time frame: 1 year
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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.