Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in the impact of fatigue on daily life
研究概览
简要总结
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks.
详细描述
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks. Individuals will continue with their current treatments in addition to following the study diet.
The study requires four visits to the University of Iowa Hospitals and Clinics in Iowa City, Iowa. Visits will be 12 weeks apart. Study activities include fasting blood draws, weighed food records, motor and cognitive testing, physical activity assessment, questionnaires, and daily diet checklists while following the study diet. Some reimbursement available.
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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to allow your neurologist to sign a letter confirming multiple sclerosis diagnosis and criteria used in diagnosis
- •Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria confirmed by their treating neurologist
- •Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4
- •Between the ages of 18 and 70
- •Body Mass Index greater than or equal to 19
- •Ability to shop for and prepare or have someone in the family shop for and prepare home cooked meals according to study diet guidelines
- •Willingness to keep detailed food records
- •Willing to eat a diet that includes more vegetables and excludes many comfort foods such as those made with white flour,
- •Willing to eat a diet that eliminates red meat (beef, pork, lamb, veal) and saturated fats (butter, coconut oil, margarine, hydrogenated oils found in processed foods) to 1 tablespoon per day
- •Must not be pregnant or planning to become pregnant in the next year
- •Willing to eat meat (eg, chicken, turkey, fish)
- •Willingness to follow either the Wahls Elimination diet or the Swank diet
- •Individuals who have had gastric bypass surgery have obtained a signed statement from their physician indicating they are weight stable and a suitable candidate for this study
- •Normal or mild cognitive impairment as measured by the Short Portable Mental Status Questionnaire
- •Willing to have blood drawn
- •Be able to walk 25 feet without support, or with only unilateral support (i.e. cane in one hand)
排除标准
- •Taking insulin or Coumadin
- •Relapse within past 12 weeks
- •Treatment for a cancer (other than skin cancer) currently or in the prior 12 months
- •Diagnosis of heart failure, liver cirrhosis, angina, history of kidney stones, psychiatric disease likely to make adherence to the study interventions more difficult including eating disorders, but excluding depression and anxiety
- •Body Mass Index less than 19
- •Moderate to severe mental impairment as measured by the Short Portable Mental Status questionnaire
- •Inability to shop for and prepare home cooked meals by the subject or a companion
- •Unwillingness to eat meat
- •Participation in another research study that involves multiple sclerosis or other medications, diet, supplement, exercise or other treatments
- •Inability to keep food records with sufficient detail to asses dietary intake or complete study questionnaires
- •Unwilling to have blood drawn
- •Pregnant or planning to become pregnant in the next year
结局指标
主要结局
Change in the impact of fatigue on daily life
时间窗: 12-36 weeks
Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.
Change in participant perceived fatigue severity
时间窗: 12-36 weeks
Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)
次要结局
- Change in participant walk speed(12-36 weeks)
- Change in participant Quality of Life (QoL) - General Health(12-36 weeks)
- Change in perceived depression(12-36 weeks)
- Change in nutrient intake based on the recommended daily allowance (RDA)(12-36 weeks)
- Change in cognitive function(12-36 weeks)
- Change in perceived anxiety(12-36 weeks)
- Change in steps per day(12-36 weeks)
- Change in participant Quality of Life (QoL) - Mental Health(12-36 weeks)
- Change in total sleep time(12-36 weeks)
- Change in gait (walk)(12-36 weeks)
- Change in fine motor function(12-36 weeks)
研究者
Terry L. Wahls
Clinical Professor
University of Iowa