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| Name | Class |
|---|---|
| Eurofins Optimed | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 2 yogurts | Experimental | consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks. |
|
| Group B: 1 yogurt | Experimental | consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product during 8 weeks. |
|
| Group C: No yogurt | No Intervention | no changes in dietary habits during 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CALIN+ | Dietary Supplement | Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum 25OHD (D2 + D3) concentration over the 16 weeks | serum 25OHD (D2 + D3) concentration will be evaluated at 4, 8, 12 and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ParaThyroid Hormone (PTH) level | Serum (ParaThyroid Hormone) PTH level | Evolution after 16 weeks consumption period |
| Serum calcium level | Serum calcium level |
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Inclusion Criteria:
Female subject, aged between 55 and 75 years inclusive.
Menopausal female subject for more than 5 years.
Non smoker or smoker less than 5 cigarettes a day
Body Mass Index (BMI) between 18 and 28 kg/m² inclusive.
Subject with a serum 25-hydroxyvitamin D2 + D3 between 10 and 30 ng/mL corresponding to a vitamin D insufficiency.
Subject with a Mini Nutritional Assessment (MNA) > 20.
Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
Normal blood pressure (BP) and heart rate (HR) at the screening visit after 10 minutes in supine position:
Subject with normal dietary habits (no vegetarian, lactose intolerant, gluten-free subject).
Having given a written informed consent prior to selection.
Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde Latreille-Barbier, MD | Eurofins Optimed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | 38610 | France |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D010024 | Osteoporosis |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C072490 | calin |
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| CALIN+ | Dietary Supplement | Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks. |
|
| Evolution after 16 weeks consumption period |
| Serum 25OHD (D2 + D3) level | Serum 25OHD (D2 + D3) level | Evolution after 16 weeks consumption period |
| Diastolic / systolic blood pressures (mm/Hg) | Diastolic / systolic blood pressures | Evolution after 16 weeks consumption period |
| Weight (kg) | Weight (kg) | Evolution after 16 weeks consumption period |
| Waist circumference (cm) | Waist circumference (com) | Evolution after 16 weeks consumption period |
| Rate constant | Rate constant | over two months |
| Serum 25OHD (D2 + D3) level | Serum 25OHD (D2 + D3) level | Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) |
| Serum ParaThyroid Hormone (PTH) level | Serum ParaThyroid Hormone (PTH) level | Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) |
| Serum calcium level | Serum calcium level | 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) | Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) |
| Weight (kg) | Weight (kg) | Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) |
| Waist circumference (cm) | Waist circumference (cm) | 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), | Evolution over the 2 months follow up period |
| Serum ParaThyroid Hormone (PTH) level | Serum ParaThyroid Hormone (PTH) level | 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 | 4 months and 6 months |
| Assessment of calcium intake using a simplified calcium questionnaire | Assessment of calcium intake using a simplified calcium questionnaire | 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 | 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) | up to 20 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |