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临床试验/NCT02835859
NCT02835859已完成不适用

Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners

AdventHealth Translational Research Institute2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年8月1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
10
试验地点
2
主要终点
Measure in glucose concentrations

研究概览

简要总结

The purpose of this study is to collect data that will help researchers better understand the various causes of obesity and diabetes; particularly to understand how consumption of NCASs affects the way the body uses nutrients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years inclusive;
  • Men and women;
  • Able to provide written, informed consent;
  • Weight stable (± 3 kg) during the 3 months prior to enrollment;
  • BMI ≤ 25 kg/m2

排除标准

  • Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or chronic obstructive pulmonary disorder, g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder;
  • Consumption of more than a can of diet beverage or a spoonful of non-caloric artificial sweeteners weekly (or each equivalent from foods) during the past month.
  • Pregnant or nursing women;
  • Current smokers (smoking within the past 3 months);
  • Known hypersensitivity to saccharin, lactisole, and acetaminophen or any of its exipients;
  • History of difficult blood sample collections or unfavorable anatomy of venous access;
  • Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents.
  • Blood pressure greater than or equal to 160/100 or less than or equal to 100/50 at screening.

结局指标

主要结局

Measure in glucose concentrations

时间窗: Measure over a 180 minute on Days 10, 15, 20, 25

Glucose concentrations will be measured by the glucose oxidase method (YSI 2300 automated analyzer) and insulin, C-peptide, GLP-1 and GLP-2 concentrations by immunoassay (Mesoscale Discovery Sector Imager 2400).

次要结局

未报告次要终点

研究者

发起方
AdventHealth Translational Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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