Amino Acid Therapy for Hot Flashes/Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.
详细描述
Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future.
Participants in this study will be randomly assigned to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal
- •Experience over 5 hot flashes per day
排除标准
- •Hormone Replacement Therapy (HRT) in the past 2 months
