Clinical trial NCT02629341: Functional Yogurt Powder Effect on Bone Health Biomarkers
Official title: Functional Yogurt Powder Effect on Bone Health Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: OSTEOPENIA
Keywords: woman osteopenia osteoporosis enriched calcium vit D yogurt
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 79
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: changes in plasma 25(OH)D concentration
timeFrame: 0 and 24 weeks
Secondary outcomes:
measure: Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)
timeFrame: 0 and 24 weeks
measure: Change from baseline calcium levels in blood
timeFrame: 0 and 24 weeks
measure: Change from baseline Parathyroid hormone (PTH)
timeFrame: 0 and 24 weeks
measure: Change from baseline adrenocorticotropic hormone (ACTH)
timeFrame: 0 and 24 weeks
measure: Change from baseline Calcitonin
timeFrame: 0 and 24 weeks
measure: Change from baseline osteocalcin
timeFrame: 0 and 24 weeks
measure: Change from baseline Osteopontin
timeFrame: 0 and 24 weeks
measure: Change from baseline Osteoprotegerin
timeFrame: 0 and 24 weeks
measure: Change from baseline sclerostin
timeFrame: 0 and 24 weeks
measure: Change from baseline phosphorus
timeFrame: 0 and 24 weeks
measure: Change from baseline N-terminal telopeptide
timeFrame: 0 and 24 weeks
measure: Change from baseline the C-terminal telopeptide
timeFrame: 0 and 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitairo La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gomez Candela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: