GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation
研究概览
简要总结
This trial studies glucosamine and chondroitin in preventing inflammation in overweight patients. Chronic inflammation contributes to cancer formation, and biomarkers of inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent inflammation and 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
- •Individuals from the Greater Seattle area who are overweight (body mass index [BMI] of 25-32.5 kg/m^2)
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
- •BMI (body mass index) < 25 or > 32.5 kg/m^2
- •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 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)
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 (Dietary Supplement)
结局指标
主要结局
Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation
时间窗: Up to 2 years
shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis \[PCOA\]).
Effects of G&C on serum C-reactive protein (CRP)
时间窗: Up to 2 years
evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual
次要结局
未报告次要终点