This study will determine if daily oral intake of 200g of a marketed yogurt with fortified calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in postmenopausal women. The efficacy of the product is measured by examining the variation of biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of bone tissue have not yet been proven.
The morbidity and mortality associated with osteoporotic related fractures is devastating in terms of disability to an individual and cost to the global economy. As the world's population ages, this will present a major public health issue since a larger proportion of women remain undiagnosed and untreated even with the availability of therapies and calcium and vitamin D supplements. Consequently, it remains important to evaluate dairy products (milk, cheese, and yogurt) that can be safely provided as a supplement for bone health in addition to the current pharmacological treatments. The rationale of this study is to assess the beneficial effect of a daily dietary supplement of MBP 80 mg in a yogurt matrix with fortified calcium content on bone remodelling in healthy early postmenopausal women with neither osteoporosis nor estrogens/progestin therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Intake of one container of vanilla or strawberry yogurt in the morning on a daily basis during 12 weeks.
G.R.M.O. Inc.
Québec, Quebec, Canada
Median percent change in levels of serum β CTX (sCTX), a bone resorption marker.
The primary efficacy variable, the median percent change from baseline (Day 0) in levels of serum β-CTX (sCTX) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum β-CTX (sCTX) at Day 0 for each participant.
Time frame: 12 weeks
Median percent change in levels of P1NP, a bone formation marker.
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of serum P1NP (sP1NP) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum P1NP(sP1NP) at Day 0 for each participant.
Time frame: 12 weeks
Median percent change in levels of serum β-CTX (sCTX), a bone resorption marker
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of serum β-CTX(sCTX) at week 4, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum β-CTX(sCTX) at Day 0 for each participant.
Time frame: 4 weeks
Median percent change in levels of urinary NTX(uNTX), a bone resorption marker.
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of urinary NTX(uNTX) at weeks 4 and 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of urinary NTX(uNTX) at Day 0 for each participant.
Time frame: weeks 4 and 12
Median percent change in levels of serum osteocalcin (sOC), a bone formation marker.
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of serum osteocalcin(sOC) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum osteocalcin(sOC) at Day 0 for each participant.
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Time frame: 12 weeks