Randomized-controlled Study for Evaluation of Ketogenic Metabolic Nutritional Pattern in Subjects With High-frequency Episodic Migraine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in migraine frequency
研究概览
简要总结
The study aims to investigate the impact of 2 nutritional patterns on high-frequency episodic migraine. Subjects enrolled will be randomized in two arms: a) very-low-calorie-ketogenic-diet (VLCKD), b) hypocaloric balanced non ketogenic-diet (HBD).
详细描述
This randomized controlled trial aims to:
- investigate the impact of very-low-calorie-ketogenic-diet (VLCKD) compared to hypocaloric balanced non ketogenic-diet (HBD) on high-frequency episodic migraine
- evaluate the impact of VLCKD or HBD on immune system, with particular regard to inflammatory and regulatory T cells
- assess aldosterone blood levels before and after VLCKD or HBD treatment The randomization will be carry out at the single center using an a proper software.
All the eligible subjects (please, see the inclusion and exclusion criteria), will be randomized in two groups. Both VLCKD or HBD will be undergone to 24 weeks of diet. For VLCKD- group, the ketogenic period will be maintained for 8 weeks. In the following four weeks, carbohydrates are gradually reintroduced, starting from foods with the lowest glycemic index (fruit, dairy products), followed by foods with moderate and high glycemic index (bread, pasta and cereals). The goal is to achieve a hypocaloric balanced diet (HBD), as well as the controlled group. From the 12th week to the 24 th week, all subjects enrolled will continue follow-up with HBD. Periodically, subjects will be monitored through physical examination (anthropometric measurements, blood pressure, heart rate, etc.) and laboratory analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index >27 kg/m2
- •Migraine onset <50 years with monthly frequency of 8-14 days in the last 3 months
- •Absence of prophylaxis therapy for migraine in the previous 3 months
- •Signing of the informed consent
- •Agreement to follow all study procedures, including follow-up visits
- •Negative pregnancy test, performed on urine sample
- •Use of contraceptive method for all participants throughout the duration of the study
- •Agreement for all study participants not to publish study information
排除标准
- •Body mass index> 35 kg / m2;
- •prophylaxis treatment for migraine in the previous 3 months
- •antidepressant and neuroleptic drugs treatment during the study (including follow-up)
- •non-potassium-sparing diuretics treatment during the study (including follow-up)
- •Use or implantation of stimulators for migraine
- •Migraine with or without excessive drug use, tension-type headache, cluster headache, sporadic or familial hemiplegic migraine, ophthalmoplegic migraine, basic migraine defined according to the ICHD-3 beta classification in the previous 3 months
- •head trauma
- •psychiatric diseases that can influence adherence to treatment
- •Type I diabetes mellitus or type II diabetes mellitus treated with insulin therapy
- •Taking supplements which affect weight
- •Taking supplements containing sugars in their composition
- •Pregnancy or breastfeeding
- •Abuse of alcohol
- •Other neurological, cardiovascular, liver, respiratory, hematologic, autoimmune diseases or alterations to laboratory tests that could compromise the study
结局指标
主要结局
Change in migraine frequency
时间窗: at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7)
Migraine Disability Assessment Score Questionnaire (MIDAS) is used in order to evaluate how severity migraine affects patient's life. MIDAS score: 0-25
次要结局
- Impact of migraine episode on daily activities(at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7))
- Weight loss(at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7))
- Change in immune system parameters(at the screening (V1),at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6))
- Health-related quality of life(at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6))
- change in analgesic consumption(through study completion, an average of 24 weeks)
- Measure of pain(at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6))