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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency

NCT02543671

Hypovitaminosis D Deficiency of Micronutrients

COMPLETED NA

Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients

NCT01229891

Type 2 Diabetes

COMPLETED PHASE2

Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice

NCT02518763

Osteoporosis

UNKNOWN PHASE3

Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

NCT01170494

Vitamin D Deficiency

COMPLETED NA

Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes

NCT01236846

Type 2 Diabetes Mellitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: 2 yogurts

consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.

Group Type EXPERIMENTAL

CALIN+

Intervention Type DIETARY_SUPPLEMENT

Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.

Group B: 1 yogurt

consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product during 8 weeks.

Group Type EXPERIMENTAL

CALIN+

Intervention Type DIETARY_SUPPLEMENT

Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks.

Group C: No yogurt

no changes in dietary habits during 24 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CALIN+

Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

CALIN+

Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes