NCT02629341

Functional Yogurt Powder Effect on Bone Health Biomarkers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: Female
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• OSTEOPENIA

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Functional yogurt powder	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
DIETARY_SUPPLEMENT	Control yogurt powder	Once daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-12-14
• Last updated: 2015-12-14

Locations

1 site across 1 country: Spain