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

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ClinicalTrials.gov Identifier: NCT02534064
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Eurofins Optimed
Information provided by (Responsible Party):
Yoplait France SAS

Brief 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.

Condition or disease Intervention/treatment Phase
Menopause Vitamin D Deficiency Dietary Supplement: CALIN+ Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effect of the Consumption of Yogurt Fortified in Calcium and Vitamin D on the Circulating Levels of 25OHD in Postmenopausal Women
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Group A: 2 yogurts
consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.
Dietary Supplement: CALIN+
Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.

Experimental: Group B: 1 yogurt
consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product during 8 weeks.
Dietary Supplement: CALIN+
Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks.

No Intervention: Group C: No yogurt
no changes in dietary habits during 24 weeks.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Serum ParaThyroid Hormone (PTH) level [ Time Frame: Evolution after 16 weeks consumption period ]
    Serum (ParaThyroid Hormone) PTH level

  2. Serum calcium level [ Time Frame: Evolution after 16 weeks consumption period ]
    Serum calcium level

  3. Serum 25OHD (D2 + D3) level [ Time Frame: Evolution after 16 weeks consumption period ]
    Serum 25OHD (D2 + D3) level

  4. Diastolic / systolic blood pressures (mm/Hg) [ Time Frame: Evolution after 16 weeks consumption period ]
    Diastolic / systolic blood pressures

  5. Weight (kg) [ Time Frame: Evolution after 16 weeks consumption period ]
    Weight (kg)

  6. Waist circumference (cm) [ Time Frame: Evolution after 16 weeks consumption period ]
    Waist circumference (com)

  7. Rate constant [ Time Frame: over two months ]
    Rate constant

  8. Serum 25OHD (D2 + D3) level [ Time Frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) ]
    Serum 25OHD (D2 + D3) level

  9. 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 ParaThyroid Hormone (PTH) level

  10. Serum calcium level [ Time Frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) ]
    Serum calcium level

  11. 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) ]
    Diastolic/systolic blood pressures (mm/Hg)

  12. Weight (kg) [ Time Frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) ]
    Weight (kg)

  13. Waist circumference (cm) [ Time Frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015) ]
    Waist circumference (cm)

  14. Serum levels of 25OHD (D2 + D3), [ Time Frame: Evolution over the 2 months follow up period ]
    Serum levels of 25OHD (D2 + D3),

  15. Serum ParaThyroid Hormone (PTH) level [ Time Frame: Evolution over the 2 months follow up period ]
    Serum ParaThyroid Hormone (PTH) level

  16. Assessment of sun exposure and dietary vitamin D intake using the Garabedian questionnaire [ Time Frame: 4 months and 6 months ]
    Assessment of sun exposure and dietary vitamin D intake using the Garabedian questionnaire

  17. 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. ]
    Assessment of calcium intake using a simplified calcium questionnaire

  18. Compliance of CALIN+ consumption reported in diary [ Time Frame: up to 20 weeks ]
    Number of consumed yogurt per day

  19. Acceptability of CALIN+ consumption by questionnaire [ Time Frame: up to 20 weeks ]
    Change from baseline in acceptability score (0: do not agree at all; 10: agree completely)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534064


Locations
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France
Eurofins Optimed
Gières, France, 38610
Sponsors and Collaborators
Yoplait France SAS
Eurofins Optimed
Investigators
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Principal Investigator: Mathilde Latreille-Barbier, MD Eurofins Optimed
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Responsible Party: Yoplait France SAS
ClinicalTrials.gov Identifier: NCT02534064    
Other Study ID Numbers: CATWIN2107
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Yoplait France SAS:
Menopause
Osteoporosis
Hip fractures
vitamin D deficiency
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders