Pilot Diet Study for Multiple Sclerosis

NCT02986893 | Completed

• 1 other identifier: GCO 16-0288
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Diet; Clinical Trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Change in Blood pressure

  Baseline, 3 months, 6 months

• Change in body mass index

  Baseline, 3 months, 6 months

• Change in lipid profile

  Baseline, 6 months

• Change in fasting glucose level

  Baseline, 6 months

• Change in hemoglobin a1c level

  Baseline, 6 months

Study Arms (2)

Dietary Intervention Arm

EXPERIMENTAL

Participants will be assigned to follow a specific dietary intervention for 6 months

Behavioral: Dietary Intervention

Non-dietary Intervention Arm

EXPERIMENTAL

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

Interventions

Dietary Intervention BEHAVIORAL

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.

Dietary Intervention Arm

Non-dietary Intervention Arm BEHAVIORAL

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.

Also known as: Monthly MS Center meeting attendance

Non-dietary Intervention Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Ilana Katz Sand, MD

  Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)