A Nutritional Intervention for Migraines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Migraines frequency
研究概览
简要总结
The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.
详细描述
Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. We will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measures are pain as measured by Visual Analog Scale (VAS)and the change in migraines frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders18
- •At least 5 attacks fulfilling criteria the criteria below
- •Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- •Headache has at least two of the following characteristics:
- •unilateral location
- •pulsating quality
- •moderate or severe pain intensity
- •aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
- •During headache at least one of the following:
- •nausea and/or vomiting
- •photophobia and phonophobia
- •Not attributed to another disorder
- •Migraines occurring at least twice per month, on average.
- •Age at least 18 years
- •Ability and willingness to participate in all components of the study
- •Willingness to be assigned to either the diet group or supplement group
- •Migraine medications unchanged within last 6 weeks.
排除标准
- •< 18 years of age
- •Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- •Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- •Unstable medical or psychiatric illness
- •Likely to be disruptive in group sessions (as determined by research staff)
- •Already following a low-fat, vegan diet
- •Lack of English fluency
- •Inability to maintain current medication regimen
- •Inability or unwillingness to participate in all components of the study
研究组 & 干预措施
Dietary Supplement
干预措施: Vegan Diet (Other)
Vegan Diet
干预措施: mixture of omega3 and vitamins (Dietary Supplement)
结局指标
主要结局
Change in Migraines frequency
时间窗: Baseline and 4 months
the reduction in the number of migraine attacks.
Migraines Pain Change in Migraines frequency
时间窗: Baseline and 4 months
Pain as measured by VAS score
次要结局
- Quality of life(Baseline and 4 months)