Effect of Consumption of Yogurt Fortified in Calcium and Vit. D on Circulating Levels of 25OHD in Postmenopausal Women

Vitamin D Deficiency Clinical Trial

Official title:

Effect of the Consumption of Yogurt Fortified in Calcium and Vitamin D on the Circulating Levels of 25OHD in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534064
• Other study ID #: CATWIN2107
• Status: Completed
• Phase: N/A
• First received: August 19, 2015
• Last updated: October 15, 2015
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Yoplait France SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female subject, aged between 55 and 75 years inclusive.

2. Menopausal female subject for more than 5 years.

3. Non smoker or smoker less than 5 cigarettes a day

4. Body Mass Index (BMI) between 18 and 28 kg/m² inclusive.

5. Subject with a serum 25-hydroxyvitamin D2 + D3 between 10 and 30 ng/mL corresponding to a vitamin D insufficiency.

6. Subject with a Mini Nutritional Assessment (MNA) > 20.

7. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

8. Normal blood pressure (BP) and heart rate (HR) at the screening visit after 10 minutes in supine position:

• 95 mmHg = systolic blood pressure (SBP) = 160 mmHg,

• 50 mmHg = diastolic blood pressure (DBP) = 95 mmHg,

• 40 bpm = HR (heart rate) = 80 bpm.

9. Subject with normal dietary habits (no vegetarian, lactose intolerant, gluten-free subject).

10. Having given a written informed consent prior to selection.

11. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

1. Subject who have taken any form of vitamin D supplementation in the 6 months preceding the study, including through fortified food (milk, dairy products, oil and tofu) or food supplements.

2. Subject who consumed more than 3 dairy products per day.

3. Functional impotence.

4. Concomitant bone disease or affecting mineral metabolism, in whatever form.

5. History of bone fracture in the previous year.

6. Presence of a primary hyperparathyroidism, chronic gastrointestinal disease or patent hepatic and/or renal impairment or a progressive severe disease.

7. Type 1 diabetic subject.

8. Subject with eating disorder.

9. Subject with a treatment which can interfere with the study purpose at the moment of recruitment or 6 months before (see section 5.6)

10. Significant allergies or food intolerance.

11. Subject who cannot be contacted in case of emergency.

12. History or presence of drug or alcohol abuse (alcohol consumption > 5 glasses / day).

13. Medical and surgical history which, in the judgment of the Investigator, is not compatible with this study.

14. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, or has poor mental development.

15. Blood donation within two months before the study beginning.

16. Subject in the exclusion period of a previous study or subject who refuse to be on the "Fichier National des Volontaires Sains".

17. Subject who refuse to sign the Informed Consent Form.

18. Participation to another study within 3 months prior the study beginning.

19. Subject under administrative or legal supervision.

20. Subject who are deprived of their liberty by judicial of administration decision.

21. Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Menopause
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• CALIN+
Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.
• CALIN+
Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks.

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières

Sponsors (2)

Lead Sponsor	Collaborator
Yoplait France SAS	Eurofins Optimed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum ParaThyroid Hormone (PTH) level	Serum (ParaThyroid Hormone) PTH level	Evolution after 16 weeks consumption period	No
Secondary	Serum calcium level	Serum calcium level	Evolution after 16 weeks consumption period	No
Secondary	Serum 25OHD (D2 + D3) level	Serum 25OHD (D2 + D3) level	Evolution after 16 weeks consumption period	No
Secondary	Diastolic / systolic blood pressures (mm/Hg)	Diastolic / systolic blood pressures	Evolution after 16 weeks consumption period	No
Secondary	Weight (kg)	Weight (kg)	Evolution after 16 weeks consumption period	No
Secondary	Waist circumference (cm)	Waist circumference (com)	Evolution after 16 weeks consumption period	No
Secondary	Rate constant	Rate constant	over two months	No
Secondary	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)	No
Secondary	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)	No
Secondary	Serum calcium level	Serum calcium level	Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)	No
Secondary	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)	No
Secondary	Weight (kg)	Weight (kg)	Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)	No
Secondary	Waist circumference (cm)	Waist circumference (cm)	Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)	No
Secondary	Serum levels of 25OHD (D2 + D3),	Serum levels of 25OHD (D2 + D3),	Evolution over the 2 months follow up period	No
Secondary	Serum ParaThyroid Hormone (PTH) level	Serum ParaThyroid Hormone (PTH) level	Evolution over the 2 months follow up period	No
Secondary	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	No
Secondary	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.	No
Secondary	Compliance of CALIN+ consumption reported in diary	Number of consumed yogurt per day	up to 20 weeks	No
Secondary	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	No