Functional Yogurt Powder Effect on Bone Health Biomarkers

NCT02629341 | Completed Phase 3 DMC

• 1 other identifier: BONEFOODS
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

OSTEOPENIA

Keywords

woman osteopenia osteoporosis enriched calcium vit D yogurt

Outcome Measures

Primary Outcomes (1)

• changes in plasma 25(OH)D concentration

  0 and 24 weeks

Secondary Outcomes (12)

• Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)

  0 and 24 weeks

• Change from baseline calcium levels in blood

  0 and 24 weeks

• Change from baseline Parathyroid hormone (PTH)

  0 and 24 weeks

• Change from baseline adrenocorticotropic hormone (ACTH)

  0 and 24 weeks

• Change from baseline Calcitonin

  0 and 24 weeks

Study Arms (2)

Functional yogurt powder

ACTIVE COMPARATOR

This arm will receive one daily serving of the functional yogurt which is enriched in Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus plantarum 3547 probiotic

Dietary Supplement: Functional yogurt powder

Control yogurt powder

PLACEBO COMPARATOR

This arm will receive one daily serving of the control yogurt which consists of a regular yogurt not enriched

Dietary Supplement: Control yogurt powder

Interventions

Functional yogurt powder DIETARY_SUPPLEMENT

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

Functional yogurt powder

Control yogurt powder DIETARY_SUPPLEMENT

Once daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt

Control yogurt powder

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With healthy weight, overweight or obesity type I (IMC ≥18.5 \<35 Kg/m2);
• With diagnosis of osteopenia without pharmacological treatment or that meet at least two of the following criteria:
• Dairy intake under 2 servings daily in the last year
• Sedentary lifestyle (measured with the International physical activity questionary IPAQ)
• Smokers of more than 5 cigarettes daily
• Signed informed consent.

You may not qualify if:

• Severe diseases (hepatic, kidney, cancer…)
• Renal failure (defined as serum creatinine level \>200 mol/L)
• Phosphate binding antacids (\> 6 months a year)
• Oral glucocorticoids (\>5 mg/day of prednison equivalent in the last 8 months or a total dose of 2g of prednison equivalent in the last 12 months)
• Local treatment with injectable glucocorticoids (\>5 injections/year)
• Treatment with inhaled glucocorticoids (\>6months in the last year and more than 2 mg/day of prednison equivalent)
• Previous or concomitant treatment for metabolic bone disease
• Use of hormone replacement therapy (oral estrogen, estradiol vaginal ring, antiestrogen, progesterone)
• Anabolic steroid use in the last 3 months or more than one in the last 6 months
• Estradiol implants in the last 3 years
• Isoflavan use in the last 6 months or more than once a month for the last 12 months
• Calcitonin use in the last month or more than 1 month in the last 6 months
• Concomitant use of nutritional supplements with silicon, horsetail extracts, bamboo, colloidal silicic acid or silanol derivatives in the last 6 months
• Hyperparathyroidism and/or hyperthyroidism
• Chronic intestinal disease (Gastritis, ulcerative colitis, irritable bowel disease, pseudomembranous colitis, inflammatory bowel disease, Crohn disease, etc)

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitairo La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carmen Gomez Candela, MD, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

ES (1)