Pilot Diet Study for Multiple Sclerosis
Completed · Not applicable
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT02986893
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 36
- Starts
- 2016-11-01
- Expected to finish
- 2018-08-31
- Last updated by the study team
- 2018-10-03
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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