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

NCT02534064 | Completed

• 1 other identifier: CATWIN2107
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Vitamin D Deficiency

Keywords

Menopause; Osteoporosis; Hip fractures; vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (19)

• 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

• Diastolic / systolic blood pressures (mm/Hg)

  Evolution after 16 weeks consumption period

• Weight (kg)

  Evolution after 16 weeks consumption period

Study Arms (3)

Group A: 2 yogurts

EXPERIMENTAL

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

Dietary Supplement: CALIN+

Group B: 1 yogurt

EXPERIMENTAL

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

Dietary Supplement: CALIN+

Group C: No yogurt

NO INTERVENTION

no changes in dietary habits during 24 weeks.

Interventions

CALIN+ DIETARY_SUPPLEMENT

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

Group A: 2 yogurts

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \> 20.
• 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:
• mmHg ≤ systolic blood pressure (SBP) ≤ 160 mmHg,
• mmHg ≤ diastolic blood pressure (DBP) ≤ 95 mmHg,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yoplait France SAS: lead
• Eurofins Optimed: collaborator

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Osteoporosis; Hip Fractures

Interventions

calin

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Mathilde Latreille-Barbier, MD

  Eurofins Optimed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 27, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

FR (1)