Pilot Diet Study for Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of a Dietary Intervention for Multiple Sclerosis (MS)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Dietary Intervention
* Behavioral: Non-dietary Intervention Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65, inclusive Female 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Intervention Arm<br>Participants will be assigned to follow a specific dietary intervention for 6 months | Behavioral: Dietary Intervention<br>* Participants will be assigned to follow a specific diet for 6 months. This will involve meetings with the study nutritionist at least monthly as well as regular assessments related to adherence and effects.<br>|
| Experimental: Non-dietary Intervention Arm<br>Participants will continue their usual diet and will be invited to attend monthly meetings at the MS Center for 6 months | Behavioral: Non-dietary Intervention Arm<br>* Participants will be requested to follow their usual diet and attend monthly meetings at the MS center to discuss various topics with a focus on wellness in MS for 6 months.<br>* Other names: Monthly MS Center meeting attendance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Frequency Questionnaire | 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. | at 6 months | 
| Carotenoids level | Adherence to the dietary intervention assessed through the carotenoid biological marker. | at 6 months | 
| Pooled fatty acids level | Adherence to the dietary intervention assessed through the pooled fatty acids biological marker. | at 6 months | 
| Urinary sodium level | Adherence to the dietary intervention assessed through the urinary sodium biological marker. | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood pressure | Change in Blood pressure at 3 months and 6 months as compared to baseline | Baseline, 3 months, 6 months | 
| Change in body mass index | Change in body mass index at 3 months and 6 months as compared to baseline | Baseline, 3 months, 6 months | 
| Change in lipid profile | Change in lipid profile at 6 months as compared to baseline | Baseline, 6 months | 
| Change in fasting glucose level | Change in fasting glucose at 6 months as compared to baseline | Baseline, 6 months | 
| Change in hemoglobin a1c level | Change in hemoglobin a1c at 6 months as compared to baseline | Baseline, 6 months | 
| Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) | Change in quality of life questionnaire scores as assessed by the Multiple Sclerosis Impact Scale-29 at 3 months and 6 months as compared to baseline. The MSIS-29 is a new measure of the physical and psychological impact of MS from the patient's perspective. Each item is scored from 1 (not at all) to 5 (extremely), with total scale from 29 to 145. | Baseline, 3 months, 6 months | 
| Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54) | Change in quality of life questionnaire scores as assessed by the Multiple Sclerosis Quality of Life-54 questionnaire at 3 months and 6 months as compared to baseline. The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. There is no single overall score for the MSQOL-54. The MSQOL-54 items are transformed linearly to 0-100 scores and final scores are obtained by averaging items within the scales. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. | Baseline, 3 months, 6 months | 
| Change in the Minimum Assessment of Cognitive Function in MS (MACFIMS) | Change at 6 months from baseline. Total range of MACFIMS from 0 (severe impairment to 282 (severe impairment) which is composed of 7 neuropsychological tests: 1) Controlled Oral Word Association Test (COWAT) score 0 (nonverbal) to 22 (normal verbal fluency; 2) Judgment of Line Orientation (JLO) score 0 (no visuospatial skills) to 30 (normal visuospatial skills); 3) California Verbal Learning Test, 2nd ed (CLVT-II) score 0 (severe deficit) to 16 (normal recall); 4) Brief Visuospatial Memory Test-Revised (BVMT-R) score 0 (poor visuospatial memory) to 12 (normal visuospatial memory); 5) Paced Auditory Serial Addition Test (PASAT) score 0 (poor cognitive function) to 60 (normal cognitive function); 6) Delis-Kaplan Executive Function System (DKEFS) score 0 (poor cognitive function) to 32 (higher levels of creative and abstract thought ); and 7) Symbol Digit Modalities Test (SDMT) score 0 (neurological impairment) to 110 (no impairment ). | Baseline, 6 months | 
| Neurological Fatigue Index-MS | Change in fatigue scale score (Neurological Fatigue Index-MS) at 6 months as compared to baseline. The Neurological Fatigue Index is a 9 item questionnaire with each item scored 1 (not appropriate) to 7 (agree). The score is calculated by the average response to the questions (adding up all the answers and dividing by 9). full range from 1 to 9 with higher value indicating more fatigue. | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Diet, Clinical Trial