NCT02534064CompletedNot Applicable
Effect of the Consumption of Yogurt Fortified in Calcium and Vitamin D on the Circulating Levels of 25OHD in Postmenopausal Women
Yoplait France SAS1 site in 1 country140 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Change of serum 25OHD (D2 + D3) concentration over the 16 weeks
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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) >
- •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:
- •95 mmHg ≤ systolic blood pressure (SBP) ≤ 160 mmHg,
- •50 mmHg ≤ diastolic blood pressure (DBP) ≤ 95 mmHg,
- •40 bpm ≤ HR (heart rate) ≤ 80 bpm.
- •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
- •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.
- •Subject who consumed more than 3 dairy products per day.
- •Functional impotence.
- •Concomitant bone disease or affecting mineral metabolism, in whatever form.
- •History of bone fracture in the previous year.
- •Presence of a primary hyperparathyroidism, chronic gastrointestinal disease or patent hepatic and/or renal impairment or a progressive severe disease.
- •Type 1 diabetic subject.
- •Subject with eating disorder.
- •Subject with a treatment which can interfere with the study purpose at the moment of recruitment or 6 months before (see section 5.6)
- •Significant allergies or food intolerance.
- •Subject who cannot be contacted in case of emergency.
- •History or presence of drug or alcohol abuse (alcohol consumption > 5 glasses / day).
- •Medical and surgical history which, in the judgment of the Investigator, is not compatible with this study.
- •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.
- •Blood donation within two months before the study beginning.
- •Subject in the exclusion period of a previous study or subject who refuse to be on the "Fichier National des Volontaires Sains".
- •Subject who refuse to sign the Informed Consent Form.
- •Participation to another study within 3 months prior the study beginning.
- •Subject under administrative or legal supervision.
- •Subject who are deprived of their liberty by judicial of administration decision.
- •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.
Arms & Interventions
Group C: No yogurt
No Intervention
no changes in dietary habits during 24 weeks.
Group A: 2 yogurts
Experimental
consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.
Intervention: CALIN+ (Dietary Supplement)
Group B: 1 yogurt
Experimental
consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product during 8 weeks.
Intervention: CALIN+ (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Serum ParaThyroid Hormone (PTH) level(Evolution over the 2 months follow up period)
- Serum calcium level(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))
- Rate constant(over two months)
- Acceptability of CALIN+ consumption by questionnaire(up to 20 weeks)
- Weight (kg)(Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015))
- Compliance of CALIN+ consumption reported in diary(up to 20 weeks)
- Diastolic/systolic blood pressures (mm/Hg)(Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015))
- Serum levels of 25OHD (D2 + D3),(Evolution over the 2 months follow up period)
- 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(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.)
- Diastolic / systolic blood pressures (mm/Hg)(Evolution after 16 weeks consumption period)
- Waist circumference (cm)(Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015))
- Serum ParaThyroid Hormone (PTH) level(Evolution after 16 weeks consumption period)
- Serum calcium level(Evolution after 16 weeks consumption period)
- Serum 25OHD (D2 + D3) level(Evolution after 16 weeks consumption period)
- Weight (kg)(Evolution after 16 weeks consumption period)
- Waist circumference (cm)(Evolution after 16 weeks consumption period)
- Serum ParaThyroid Hormone (PTH) level(Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015))
Investigators
Study Sites (1)
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