Pilot Study of a Dietary Intervention for Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Urinary sodium level
研究概览
简要总结
The goal of this project is to establish the feasibility of dietary research in Multiple Sclerosis (MS) patients as well as to provide preliminary data to support future clinical trials of diet in MS. This project is a pilot randomized trial of a dietary intervention in MS patients. The dietary intervention was designed to include dietary components that have been suggested to be of benefit in MS through basic science research and observational-type studies in MS patients and to exclude those that have been suggested to be detrimental. It is therefore rich in foods that are high in polyunsaturated fatty acids (particularly omega-3 fatty acids), foods that are high in polyphenols and antioxidant vitamins such as berries and other fruits and vegetables, as well as whole grains, and excludes meat other than fish as well as dairy and refined sugars and limits salt. Subjects are randomly assigned to the dietary intervention or to the non-intervention group. The non-intervention group will be invited to attend regular meetings with a focus on wellness in MS however will not receive specific dietary instructions. At the end of the study those who were not in the dietary intervention group will have the opportunity to receive all of the materials used during the study should they wish to begin the diet.
详细描述
This is a pilot study of a carefully-designed dietary intervention that aims to help overcome obstacles to diet research in MS as well as provide needed preliminary data for future clinical trials. It incorporates elements with suggested benefits for MS including foods high in polyunsaturated fatty acids, polyphenols, and antioxidants, and excludes those that are potentially detrimental such as dairy and saturated fat from meat, refined sugars, and also limits salt content.
The 15 participants randomized to the dietary intervention arm will undergo intensive training with a nutritionist and the PI regarding the mechanics of the diet. Menu suggestions, recipes, and grocery lists will be provided. This will be followed by regular meetings and contact with all study participants by e-mail and phone to maximize dietary adherence. The 15 subjects not in the dietary intervention group will have regular meetings at the center with a focus on wellness in MS in general. Adherence to the diet will be assessed through the use of multiple validated dietary questionnaires as well as through biological specimen analysis. Feedback will be requested to provide valuable advice from participants that can be applied to future clinical trials. Effects on general health and wellness outcomes such as BMI, lipid profile, fasting glucose, hemoglobin a1c, blood pressure, as well as effects on fatigue and cognition will be explored. Fecal specimens for microbiota analysis and blood samples for immunological profiling will be collected and stored for future analysis to help elucidate potential mechanisms for dietary effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-65, inclusive
- •Self-reported race of white or black
- •Diagnosis of CIS with MRI consistent with MS, RRMS, or PPMS by McDonald 2010 criteria or SPMS by Lublin 2014 definition
- •If the subject is receiving treatment with disease-modifying therapy, must be on that therapy for at least 3 months prior to randomization
- •Willing and able to be randomized to dietary intervention with commitment to rigorously follow the dietary protocol and complete the necessary assessments over 6 months
排除标准
- •MS exacerbation within 60 days of protocol start
- •Intravenous corticosteroids within 60 days of protocol start
- •Patients with severe medical or psychiatric illness that would interfere with their ability to comply with the protocol, or potentially cause the patient harm as determined by the treating physician
- •Active smoking at the time of protocol start
- •Taking supplements other than approved doses of vitamin D within 1 month of study start
- •Pregnancy or planning pregnancy during the study period, breastfeeding
研究组 & 干预措施
Dietary Intervention Arm
Participants will be assigned to follow a specific dietary intervention for 6 months
干预措施: Dietary Intervention (Behavioral)
Non-dietary Intervention Arm
Participants will continue their usual diet and will be invited to attend monthly meetings at the MS Center for 6 months
干预措施: Non-dietary Intervention Arm (Behavioral)
结局指标
主要结局
Urinary sodium level
时间窗: at 6 months
Adherence to the dietary intervention assessed through the urinary sodium biological marker.
Food Frequency Questionnaire
时间窗: at 6 months
Adherence to the dietary intervention will be assessed through the food frequency questionnaire. This full-length (approximately 110 food item) questionnaire was designed to estimate usual and customary intake of a wide array of nutrients and food groups. Calculations are estimated via computerized software programs.
Pooled fatty acids level
时间窗: at 6 months
Adherence to the dietary intervention assessed through the pooled fatty acids biological marker.
Carotenoids level
时间窗: at 6 months
Adherence to the dietary intervention assessed through the carotenoid biological marker.
次要结局
- Change in Blood pressure(Baseline, 3 months, 6 months)
- Change in lipid profile(Baseline, 6 months)
- Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)(Baseline, 3 months, 6 months)
- Neurological Fatigue Index-MS(Baseline, 6 months)
- Change in fasting glucose level(Baseline, 6 months)
- Change in hemoglobin a1c level(Baseline, 6 months)
- Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54)(Baseline, 3 months, 6 months)
- Change in body mass index(Baseline, 3 months, 6 months)
- Change in the Minimum Assessment of Cognitive Function in MS (MACFIMS)(Baseline, 6 months)