Effect of Camel Milk Containing Bifidobacterium Animalis A6 on Chinese People With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL
研究概览
简要总结
The purpose of this study is to investigate the effects of dietary supplement with Camel Milk containing Bifidobacterium animalis A6 on the plasma glucose and other related cytokines in patients with type 2 diabetes mellitus. 45 patients with type 2 diabetes mellitus were recruited, and a Double Blind Randomized Parallel Controlled Trial was performed. The fasting glycaemia, 2 hour postprandial glycaemia, insulin, uric acid and serum lipid (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol ) were measured as Primary Outcome. The Fecal microbiome, fecal metabolites, gut hormones (amylin, ghrelin, glucagon-like peptide 1, pancreatic polypeptide), inflammation cytokines (TNF-α, IL-6, MCP-1), myokines (FGF-21, irisin, osteocrin/musclin, osteonectin) and adipokines (adiponectin, resistin, lipocalin-2, adipsin) and body composition analysis were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35~68 years old
- •Patients who diagnosed as type 2 diabetes
- •Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) and antibiotic
- •Agree to sign the informed consent form
排除标准
- •Taking antibiotics or antifungal drugs within 7 days before the study
- •Have serious allergic reaction to skim milk powder or milk
- •Researcher are not sure whether the subjects are willing or able to complete the study
- •Subject had other serious diseases
结局指标
主要结局
Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL
时间窗: 4 weeks
follow up the patients at week 0, 4
Changes in lipid profiles (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol in millimole per liter)
时间窗: 4 weeks
follow up the patients at week 0, 4
次要结局
- Changes in fecal microbiome(4 weeks)
- Fecal metabolites were identified by GC-MS after extracted with methanol, then oximated with methoxyamine hydrochloride and trimethylsilylated with BSTFA. The concentration was calculated as the area of the peak and normalized to the internal standard.(4 weeks)
- Changes in gut hormones (amylin, ghrelin, GLP-1, PP and PYY in petagram per milliliter)(4 weeks)
- Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter)(4 weeks)
- Changes in body composition (bodyweight in kilograms, height in meters and visceral fat content in square centimeters and body fat in % were measured using the bioelectrical impedance method (BAS-H, SEEHIGHER, Beijing China). )(4 weeks)
- Changes in myokines (FGF21, irisin, osteocrin, and osteonectin in petagram per milliliter) and adipokines (adiponectin and adipsin in microgram per milliliter and resistin and lipocalin-2 in petagram per milliliter)(4 weeks)
研究者
Fazheng Ren
Professor
China Agricultural University