Functional Yogurt Powder Effect on Bone Health Biomarkers
Condition: OSTEOPENIA
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the therapeutic effect of a functional yogurt
      powder on menopausal, middle-aged women at high risk of osteoporosis. The functional yogurt
      powder containing Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus plantarum
      3547 probiotic, was developed to benefit bone health and in the long term may contribute to
      the prevention of osteoporosis.
    

Detailed description: 
      Randomized, parallel, double-blind, placebo controlled clinical trial to evaluate the effect
      of a functional yogurt powder on bone health biomarkers in menopause, middle-aged women at
      high risk of osteoporosis.

      78 volunteers will be recruited at the La Paz University Hospital of Madrid. Participants
      should meet the next inclusion criteria: being menopausal, aged between 50 and 65 years,
      IMC≥18.5 <35 Kg/m2 and having a diagnosis of osteopenia without pharmacological treatment
      (Volunteers without osteopenia diagnosis should meet two of the next: dairy intake under 2
      servings a day, sedentary lifestyle and/or smokers of more than 5 cigarettes a day).

      Participants will be randomized in two arms:

        1. Functional yogurt powder arm: they will receive over 24 weeks a daily serving of the
           functional yogurt powder containing Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the
           Lactobacillus plantarum 3547 probiotic.

        2. Control yogurt powder arm: they will receive over 24 weeks a daily serving of the
           control yogurt powder (not enriched).

      All participants will be advised to follow a healthy diet and practice physical activity.

      Follow up will include 3 individualized visits and 4 group visits to check the product intake
      compliance and the tolerance to the product. The primary outcome, vitamin D level, will be
      measured at the beginning (basal condition) and at the end of the intervention (24 weeks).
      Other bone health biomarkers (Parathyroid hormone (PTH) calcium, phosphorus, calcitonin,
      osteocalcin, adrenocorticotropic hormone (ACTH),osteopontin, osteoprotegerin, sclerostin,the
      N-terminal telopeptide (NTx) and C-terminal telopeptide CTx) and safety issues (transaminases
      and creatinine) will be measured at the same time points (0 and 24 weeks).
    

Intervention name(s): Functional yogurt powder; Control yogurt powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Once daily during 24 weeks, 150g of yogurt powder enriched with:
Calcium (mg) 501 D3 Vitamin (Colecalciferol) (μg(UI)) 6(240) K Vitamin (μg) 80 C Vitamin (mg) 100 Zinc (mg) 10,39 Magnesium (mg) 250,5 L-Leucin (g) 1 Lactobacillus plantarum 3547 (ufc) 1x10e10; Once daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: woman osteopenia osteoporosis enriched calcium vit D yogurt