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Multiple SclerosisNCT02986893

Pilot Diet Study for Multiple Sclerosis

A study testing Dietary Intervention and Non-dietary Intervention Arm in people with Multiple Sclerosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Multiple Sclerosis
What is being tested?
Dietary Intervention and Non-dietary Intervention Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Nov 2016to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Dietary Intervention, Non-dietary Intervention Arm
Keywords
Multiple Sclerosis, Diet, Clinical Trial
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary InterventionBehavioural

    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.

  • Non-dietary Intervention ArmBehavioural

    Also called Monthly MS Center meeting attendance

    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.

Study groups in NCT02986893
Study groupRoleWhat they receive
Dietary Intervention ArmExperimentalParticipants will be assigned to follow a specific dietary intervention for 6 months
Receives: Behavioral: Dietary Intervention
Non-dietary Intervention ArmExperimentalParticipants will continue their usual diet and will be invited to attend monthly meetings at the MS Center for 6 months
Receives: Behavioral: Non-dietary Intervention Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 6 months

  2. Carotenoids level

    Adherence to the dietary intervention assessed through the carotenoid biological marker.

    Measured: at 6 months

  3. Pooled fatty acids level

    Adherence to the dietary intervention assessed through the pooled fatty acids biological marker.

    Measured: at 6 months

  4. Urinary sodium level

    Adherence to the dietary intervention assessed through the urinary sodium biological marker.

    Measured: at 6 months

Secondary outcomes (9)

  1. Change in Blood pressure

    Change in Blood pressure at 3 months and 6 months as compared to baseline

    Measured: Baseline, 3 months, 6 months

  2. Change in body mass index

    Change in body mass index at 3 months and 6 months as compared to baseline

    Measured: Baseline, 3 months, 6 months

  3. Change in lipid profile

    Change in lipid profile at 6 months as compared to baseline

    Measured: Baseline, 6 months

  4. Change in fasting glucose level

    Change in fasting glucose at 6 months as compared to baseline

    Measured: Baseline, 6 months

  5. Change in hemoglobin a1c level

    Change in hemoglobin a1c at 6 months as compared to baseline

    Measured: Baseline, 6 months

  6. 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.

    Measured: Baseline, 3 months, 6 months

  7. 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.

    Measured: Baseline, 3 months, 6 months

  8. 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 ).

    Measured: Baseline, 6 months

  9. 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.

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986893
Sponsor's protocol ID
GCO 16-0288
Status last verified
Oct 2018
First submitted
6 Dec 2016
Last updated
3 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Intervention and Non-dietary Intervention Arm in people with Multiple Sclerosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food Frequency Questionnaire (time frame: at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02986893.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.

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