NCT03032640已完成不适用
Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
AdventHealth Translational Research Institute2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2017年1月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.
研究概览
简要总结
The purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood sugar levels and in the composition of the bacteria in the large intestine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent
- •Age 18-45 years
- •Weight stable (± 3 kg) during the 6 months prior to enrollment
- •BMI ≤ 25 kg/m2
- •Consumption of less than a can of diet beverage or a spoonful of NCASs weekly (or each equivalent from foods) during the past month
排除标准
- •Known coronary artery disease, angina or congestive heart failure
- •Type 1 or Type 2 Diabetes (A1c ≥6.5%)
- •Bleeding disorders
- •Hemoglobin level < 12.5 g/dL for women; hemoglobin level < 13.0 g/dL for men
- •Acute or chronic infections
- •Hepatitis and/or cirrhosis
- •Severe asthma or chronic obstructive pulmonary disease
- •Renal insufficiency or nephritis (creatinine > 1.6 mg/dl)
- •Prior bariatric surgery
- •Inflammatory bowel disease or malabsorption
- •Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
- •Psychiatric disorders or eating disorders
- •Cushing's disease or syndrome
- •Untreated or inadequately controlled hypo- or hyperthyroidism (abnormal TSH)
- •Active rheumatoid arthritis or other inflammatory rheumatic disorder
- •Pregnant or nursing women
- •Smoking (smoking within the past 3 months)
- •Less than 4 bowel movements per week
- •Known hypersensitivity to saccharin, lactisole or any of its excipients.
- •Excluded medications include but are not limited to:
- •Anti-diabetic agents
- •Oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable)
- •Antibiotic use (within the past 3 months)
- •Other drugs known to affect immune or metabolic function
- •Orlistat, phentermine, topiramate or other weight loss or anorectic agents (tricyclic antidepressants, atypical antipsychotics or other psychiatric drugs with effects on body weight)
结局指标
主要结局
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.
时间窗: 6 weeks
次要结局
- Short chain fatty acid analyses(6 weeks)
研究者
研究点 (2)
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