The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+ pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women.
The active form of vitamin D is produced by skin when it is exposed to ultraviolet-B (UVB) rays. However, because of our sedentary lifestyle and to the low sun exposure during winter, the vitamin D status is most frequently deficient. Hence the consumption of enriched food could be an efficient strategy to improve vitamin D status. The current recommendation for vitamin D intake is 20 µg per day for adults (19-50 yo) and between 25 and 37.5 µg per day for people over 50 years old according to the French National Medicine Academy. However, the recommended daily allowance (RDA) in France for vitamin D is limited to 5 µg corresponding to the maximum enrichment allowed in a food product. The current study is designed to evaluate if a daily consumption of two CALIN+ yogurts enriched with 5µg of vitamin D is sufficient to improve the vitamin D status in postmenopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
140
Eurofins Optimed
Gières, France
Change of serum 25OHD (D2 + D3) concentration over the 16 weeks
Time frame: serum 25OHD (D2 + D3) concentration will be evaluated at 4, 8, 12 and 16 weeks
Serum ParaThyroid Hormone (PTH) level
Serum (ParaThyroid Hormone) PTH level
Time frame: Evolution after 16 weeks consumption period
Serum calcium level
Serum calcium level
Time frame: Evolution after 16 weeks consumption period
Serum 25OHD (D2 + D3) level
Serum 25OHD (D2 + D3) level
Time frame: Evolution after 16 weeks consumption period
Diastolic / systolic blood pressures (mm/Hg)
Diastolic / systolic blood pressures
Time frame: Evolution after 16 weeks consumption period
Weight (kg)
Weight (kg)
Time frame: Evolution after 16 weeks consumption period
Waist circumference (cm)
Waist circumference (com)
Time frame: Evolution after 16 weeks consumption period
Rate constant
Rate constant
Time frame: over two months
Serum 25OHD (D2 + D3) level
Serum 25OHD (D2 + D3) level
Time frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
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Serum ParaThyroid Hormone (PTH) level
Serum ParaThyroid Hormone (PTH) level
Time frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Serum calcium level
Serum calcium level
Time frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Diastolic/systolic blood pressures (mm/Hg)
Diastolic/systolic blood pressures (mm/Hg)
Time frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Weight (kg)
Weight (kg)
Time frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Waist circumference (cm)
Waist circumference (cm)
Time frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Serum levels of 25OHD (D2 + D3),
Serum levels of 25OHD (D2 + D3),
Time frame: Evolution over the 2 months follow up period
Serum ParaThyroid Hormone (PTH) level
Serum ParaThyroid Hormone (PTH) level
Time frame: Evolution over the 2 months follow up period
Assessment of sun exposure and dietary vitamin D intake using the Garabedian questionnaire
Assessment of sun exposure and dietary vitamin D intake using the Garabedian questionnaire
Time frame: 4 months and 6 months
Assessment of calcium intake using a simplified calcium questionnaire
Assessment of calcium intake using a simplified calcium questionnaire
Time frame: over the 16-week consumption period and over the first 8 weeks consumption for women included in the study during the winter season, i.e. before March 1, 2015.
Compliance of CALIN+ consumption reported in diary
Number of consumed yogurt per day
Time frame: up to 20 weeks
Acceptability of CALIN+ consumption by questionnaire
Change from baseline in acceptability score (0: do not agree at all; 10: agree completely)
Time frame: up to 20 weeks