Functional Yogurt Powder Effect on Bone Health Biomarkers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- changes in plasma 25(OH)D concentration
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
changes in plasma 25(OH)D concentration
时间窗: 0 and 24 weeks
次要结局
- Change from baseline Osteoprotegerin(0 and 24 weeks)
- Change from baseline calcium levels in blood(0 and 24 weeks)
- Change from baseline adrenocorticotropic hormone (ACTH)(0 and 24 weeks)
- Change from baseline Osteopontin(0 and 24 weeks)
- Change from baseline sclerostin(0 and 24 weeks)
- Change from baseline the C-terminal telopeptide(0 and 24 weeks)
- Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)(0 and 24 weeks)
- Change from baseline Parathyroid hormone (PTH)(0 and 24 weeks)
- Change from baseline Calcitonin(0 and 24 weeks)
- Change from baseline osteocalcin(0 and 24 weeks)
- Change from baseline phosphorus(0 and 24 weeks)
- Change from baseline N-terminal telopeptide(0 and 24 weeks)