Pilot Diet Study for Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/5/2018 |
| Start Date: | November 2016 |
| End Date: | August 31, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Ilana Katz Sand, MD
Phone: 212-241-6854
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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