- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986893
Pilot Diet Study for Multiple Sclerosis
Pilot Study of a Dietary Intervention for Multiple Sclerosis (MS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary Intervention Arm
Participants will be assigned to follow a specific dietary intervention for 6 months
|
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.
|
Experimental: 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
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Frequency Questionnaire
Time Frame: 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.
|
at 6 months
|
Carotenoids level
Time Frame: at 6 months
|
Adherence to the dietary intervention assessed through the carotenoid biological marker.
|
at 6 months
|
Pooled fatty acids level
Time Frame: at 6 months
|
Adherence to the dietary intervention assessed through the pooled fatty acids biological marker.
|
at 6 months
|
Urinary sodium level
Time Frame: at 6 months
|
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
Time Frame: Baseline, 3 months, 6 months
|
Change in Blood pressure at 3 months and 6 months as compared to baseline
|
Baseline, 3 months, 6 months
|
Change in body mass index
Time Frame: Baseline, 3 months, 6 months
|
Change in body mass index at 3 months and 6 months as compared to baseline
|
Baseline, 3 months, 6 months
|
Change in lipid profile
Time Frame: Baseline, 6 months
|
Change in lipid profile at 6 months as compared to baseline
|
Baseline, 6 months
|
Change in fasting glucose level
Time Frame: Baseline, 6 months
|
Change in fasting glucose at 6 months as compared to baseline
|
Baseline, 6 months
|
Change in hemoglobin a1c level
Time Frame: Baseline, 6 months
|
Change in hemoglobin a1c at 6 months as compared to baseline
|
Baseline, 6 months
|
Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time Frame: Baseline, 3 months, 6 months
|
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)
Time Frame: Baseline, 3 months, 6 months
|
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)
Time Frame: Baseline, 6 months
|
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
Time Frame: Baseline, 6 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ilana Katz Sand, MD, Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 16-0288
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Dietary Intervention
-
University of ViennaCompletedEndotoxemia | Dietary HabitsAustria
-
Azienda Ospedaliero-Universitaria CareggiRecruiting
-
Brown UniversityNational Cancer Institute (NCI)UnknownUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Brown UniversityNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
University Hospital, Strasbourg, FranceRecruitingDigestive Cancer | UndernourishedFrance
-
Josephine Ford Cancer CenterNational Cancer Institute (NCI)UnknownUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of South CarolinaAcademy of Nutrition and DieteticsCompleted
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedCaloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast CancerBreast Carcinoma | Endometrial Carcinoma | Prostate CarcinosarcomaUnited States