Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D

Elvir SAS

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Dietary Supplement: Anthocyans, Calcium and Vitamin D; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00663221

LC2 Atlas

Details and patient eligibility

About

We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.

Enrollment: 56 estimated patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women
• Aged between 50 and 65 years
• Between 1 and 5 years menopause
• IMC between 19 and 30 kg/m²

Exclusion criteria

• Medical Treatment for bone metabolism
• Vitamin D not including in the range of 20nmoles<25(OH)<100nmoles/l
• Vegan and vegetarian diet
• Regular consumption of food supplementary benefits
• Lactose intolerance
• While dieting

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

56 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Dietary Supplement: placebo

2

Experimental group

Treatment:

Dietary Supplement: Anthocyans, Calcium and Vitamin D