Functional Yogurt Powder Effect on Bone Health Biomarkers

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

OSTEOPENIA

Clinical Trial Details

NCT number	NCT02629341
Study type	Interventional
Source	Instituto de Investigación Hospital Universitario La Paz
Contact
Status	Completed
Phase	Phase 3
Start date	January 2015
Completion date	July 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Active, not recruiting	`NCT05066477` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women	N/A
Terminated	`NCT01902186` - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir	Phase 4
Completed	`NCT01439139` - Bone UltraSonic Scanner (BUSS): Validation Study	N/A
Not yet recruiting	`NCT01397838` - Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women	Phase 1
Completed	`NCT01222026` - Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate	Phase 4
Completed	`NCT01152580` - Melatonin Osteoporosis Prevention Study	Phase 1
Completed	`NCT00789425` - Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women	Phase 2
Completed	`NCT00655681` - Prevention of Post Operative Bone Loss in Children	N/A
Completed	`NCT00463268` - Osteoporosis Prevention With Low Dose Alendronate	Phase 3
Completed	`NCT00798473` - Zoledronate for Osteopenia in Pediatric Crohn's	Phase 3
Active, not recruiting	`NCT00076050` - Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms	Phase 3
Completed	`NCT00226031` - Optimal Management of Women With Wrist Fractures	N/A
Enrolling by invitation	`NCT04752098` - A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method	N/A
Completed	`NCT04720833` - Effect of Dried Plum on Bone and Markers of Bone Status in Men	N/A
Recruiting	`NCT05541432` - Finding the Optimal Resistance Training Intensity For Your Bones	N/A
Active, not recruiting	`NCT05405894` - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Completed	`NCT05457036` - Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile	N/A
Completed	`NCT04040010` - The Effects of Bovine Colostrum in Bone Metabolism in Humans	N/A
Completed	`NCT02731820` - Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Functional Yogurt Powder Effect on Bone Health Biomarkers — bonefoods

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms