Conjugated Linoleic Acid (CLA) as Adjunctive Therapy in Mild Asthmatics: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- PC20 - methacholine sensitivity
研究概览
简要总结
Conjugated linoleic acids (CLA) are naturally occurring free fatty acids derived from the tissues and milk of ruminant animals such as cows. CLA has multiple biological properties including regulation of metabolism and immune processes, including tissue inflammation. Asthma symptoms are caused by irritation and inflammation of the airways. Our hypothesis was that CLA may reduce airway inflammation in asthma and thus reduce asthma symptoms. The aim of this pilot study was to investigate the efficacy and safety of CLA as a dietary supplement in mild asthma. Subjects will be assigned to take CLA dietary supplements or placebo (olive oil) for 12 weeks in addition to their usual asthma treatment. They will be monitored for asthma symptoms, side effects, lung function and blood markers of inflammation.
详细描述
Background and Purpose You are being invited to participate in a study of the effects of a natural supplement, conjugated linoleic acid (CLA), on allergy and asthma. Previous studies show that CLA may control the type of inflammation found in allergy and asthma. CLA is found in dairy products, however the amount found varies greatly depending on what the cows have been fed and has reduced dramatically over the last 30 years. The estimated daily intake of CLA is between 15 and 174 mg/day, but an effective dose of CLA is 3000 to 4000 mg/day for a 70 kg adult. Therefore taking CLA supplements may be beneficial. This will be the first formal study to look at whether CLA does benefit people with allergies and asthma.
Study Procedures
If you qualify for the study and agree to participate, you will be randomly assigned (like flipping a coin) into one of two groups. The two groups are:
Conjugated linoleic acid (active substance) twice daily for 3 months Placebo (inactive substance) twice daily for 3 months
Neither you nor the study doctors will know whether you are receiving CLA or placebo. There will be no change in your asthma medications that are prescribed by your regular physician. Your physician will be made aware that you are participating in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild asthma - FEV1 > 70% predicted Positive methacholine challenge
排除标准
- 未提供
研究组 & 干预措施
2
Olive oil 4.5g/day x 12 weeks.
干预措施: Olive oil (Dietary Supplement)
1
Conjugated Linoleic Acid 4.5g/day in three divided doses p.o. for 12 weeks
干预措施: Conjugated Linoleic Acid (CLA) (Dietary Supplement)
结局指标
主要结局
PC20 - methacholine sensitivity
时间窗: 12 weeks
次要结局
- Quality of life (QoL), body mass index (BMI), systemic cytokine levels, and adverse events.(12 weeks)