GLANCE2.1 - Glucosamine and Chondroitin (G&C) Effects Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of participants that experienced a shift in bacterial community assessed by operational taxonomic units
研究概览
简要总结
This trial studies glucosamine and chondroitin in preventing inflammation. Glucosamine and chondroitin often used as a dietary supplement to promote joint health may have a preventive role in inflammation and cancer. This trial may help identify the bacteria that help process them in the gut.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •From the Greater Seattle area
排除标准
- •Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases)
- •Pregnancy or lactation
- •Currently on a weight-loss diet
- •Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits)
- •Current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or use of aspirin or NSAIDs more than 2 days per week
- •Abnormal renal, liver or metabolic test
- •Inability to swallow pills
- •Known allergy to shellfish
- •Not willing to take pills made from shellfish or animal sources
- •Intention to relocate out of study area within next 2 months
- •Any antibiotic use in the past 6 months
研究组 & 干预措施
Arm I (glucosamine sulfate/chondroitin sulfate tablet)
Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II.
干预措施: Glucosamine Sulfate/Chondroitin Sulfate Tablet (Dietary Supplement)
Arm II (placebo)
Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I.
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants that experienced a shift in bacterial community assessed by operational taxonomic units
时间窗: Up to 2 years
Shifts in the bacterial communities is based on clustering of operational taxonomic units (OTU) at 97% similarity
次要结局
未报告次要终点