NCT05332626已完成不适用
Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal in Women?
Poznan University of Life Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Calcium
研究概览
简要总结
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
详细描述
This study has three steps; namely, 1st step is to prepare the diet supplementation of probiotics and placebo. 2nd step is to perform the randomized, double-blind placebo-controlled clinical trial. 3rd step is to analyze the effects of L. acidophilus UALa-01™ in postmenopausal women.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 45 to 70 years old with more than one year since last menstruation;
- •Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- •All female participants who accepted bone densitometry measurement
排除标准
- •The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
- •Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
- •Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
- •Clinically significant acute inflammatory process (elevated hsCRP)
- •Abnormal kidney function (GFR <60mL/min/1,73m2);
- •Participation in a body mass management study;
- •The use of drugs known to modify body mass or food intake;
- •Hormone replacement therapy;
- •History of following alternative diets (diets with the altered amount of macronutrients, vegan or vegetarian diets, high-fiber diet, a diet with high quantities of fermented food (>400 g/day), diet fortified with prebiotics- and probiotics-functional food, elimination diets, low-calorie diets) within three months before the study;
- •History of use of any dietary supplements, including calcium, in the three months before the study;
- •History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study;
- •Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention;
- •Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- •Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- •Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
- •Diseases requiring nutritional requirement and chronic supplementation;
- •Alcohol (>20g/d), nicotine or drug abuse;
- •Mental disorders, including eating disorders;
- •Cancer, autoimmune diseases;
- •Any other condition that, in the opinion of the investigators, would make participation not in the best interest of the subject, or could prevent, limit, or confound the efficacy of the study any diseases, disorders, and therapies, which may influence on final results of the study or pose a risk for subjects health.
研究组 & 干预措施
Probiotic group
Experimental
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10^9 CFU for 12 weeks
干预措施: Probiotic group (Dietary Supplement)
Placebo group
Placebo Comparator
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
干预措施: Placebo group (Dietary Supplement)
结局指标
主要结局
Calcium
时间窗: 2 years
measure the calcium concentration in serum and hair
DXA
时间窗: 2 years
bone densitometry analysis
次要结局
- Body Mass(2 years)
- Calcium Intake(2 years)
- Biomarkers of Bone Turnover: CTX(2 years)
- Biomarkers of Bone Turnover: TRAP5b(2 years)
- Biomarkers of Bone Resorption: BSAP(2 years)
- Biomarkers of Bone Resorption: PINP(2 years)
研究者
Iskandar Harahap
Principal Investigator
Poznan University of Life Sciences
研究点 (1)
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