Functional Yogurt Powder Effect on Bone Health Biomarkers

OSTEOPENIA Clinical Trial

— bonefoods  

Official title:

Functional Yogurt Powder Effect on Bone Health Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629341
• Other study ID #: BONEFOODS
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2015
• Last updated: December 10, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

• Dementia, mental disease or diminished cognitive function

• Mayor surgery in the last month or gastrointestinal surgery in the last 3 months

• Prebiotic, probiotic ad/or symbiotic consumption, antioxidant supplements, supplements with omega 3, vitamins or minerals in the last 2 weeks prior to the start of the study

• Participation in programs and / or drug use for weight control in the last 6 months

• Alcohol consumption over 30g/day

• Habitual laxative use and non acceptance in giving up its use during the study

• Individuals using topic glucocorticoids can enter the trial

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

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitairo La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in plasma 25(OH)D concentration		0 and 24 weeks	Yes
Secondary	Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)		0 and 24 weeks	Yes
Secondary	Change from baseline calcium levels in blood		0 and 24 weeks	Yes
Secondary	Change from baseline Parathyroid hormone (PTH)		0 and 24 weeks	Yes
Secondary	Change from baseline adrenocorticotropic hormone (ACTH)		0 and 24 weeks	Yes
Secondary	Change from baseline Calcitonin		0 and 24 weeks	Yes
Secondary	Change from baseline osteocalcin		0 and 24 weeks	Yes
Secondary	Change from baseline Osteopontin		0 and 24 weeks	Yes
Secondary	Change from baseline Osteoprotegerin		0 and 24 weeks	Yes
Secondary	Change from baseline sclerostin		0 and 24 weeks	Yes
Secondary	Change from baseline phosphorus		0 and 24 weeks	Yes
Secondary	Change from baseline N-terminal telopeptide		0 and 24 weeks	Yes
Secondary	Change from baseline the C-terminal telopeptide		0 and 24 weeks	Yes