A Nutritional Intervention for Migraines-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Improvement in Mood
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.This study also tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
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. The investigators 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.
Mood change will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
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 100 Years（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 Disorders:
- •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)
- •Pregnancy
- •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
Vegan diet
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.
干预措施: Plant based diet (Other)
Supplement group
The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.
干预措施: an unrestricted diet (Other)
结局指标
主要结局
Improvement in Mood
时间窗: Baseline and 4 months
mood changes will be measured using the Beck Depression Inventory II (BDI-II).
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)