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

October 15, 2015 updated by: Yoplait France SAS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France, 38610
        • Eurofins Optimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: CALIN+
Consumption of 1 CALIN+ pot 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 2 CALIN+ pots per day during 16 weeks and follow up without product intake 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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 25OHD (D2 + D3) concentration will be evaluated at 4, 8, 12 and 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum ParaThyroid Hormone (PTH) level
Time Frame: Evolution after 16 weeks consumption period
Serum (ParaThyroid Hormone) PTH level
Evolution after 16 weeks consumption period
Serum calcium level
Time Frame: Evolution after 16 weeks consumption period
Serum calcium level
Evolution after 16 weeks consumption period
Serum 25OHD (D2 + D3) level
Time Frame: Evolution after 16 weeks consumption period
Serum 25OHD (D2 + D3) level
Evolution after 16 weeks consumption period
Diastolic / systolic blood pressures (mm/Hg)
Time Frame: Evolution after 16 weeks consumption period
Diastolic / systolic blood pressures
Evolution after 16 weeks consumption period
Weight (kg)
Time Frame: Evolution after 16 weeks consumption period
Weight (kg)
Evolution after 16 weeks consumption period
Waist circumference (cm)
Time Frame: Evolution after 16 weeks consumption period
Waist circumference (com)
Evolution after 16 weeks consumption period
Rate constant
Time Frame: over two months
Rate constant
over two months
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
Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
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
Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
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
Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
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)
Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Weight (kg)
Time Frame: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Weight (kg)
Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
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)
Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)
Serum levels of 25OHD (D2 + D3),
Time Frame: Evolution over the 2 months follow up period
Serum levels of 25OHD (D2 + D3),
Evolution over the 2 months follow up period
Serum ParaThyroid Hormone (PTH) level
Time Frame: Evolution over the 2 months follow up period
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
Time Frame: 4 months and 6 months
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
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
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
Time Frame: up to 20 weeks
Number of consumed yogurt per day
up to 20 weeks
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)
up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yoplait France SAS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eurofins Optimed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CATWIN2107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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