Novel Immune Markers in Patients With Multiple Sclerosis (NIMMS)

Quantification of Novel Immune Markers in Human Serum of Patients With MS

The investigators hypothesize that the endogenous cannabinoid signalling system has lost homeostasis in the disease multiple sclerosis (MS). To investigate a novel action of dietary fish oils, the investigators will administer a food frequency questionnaire to both healthy subjects and patients with MS. The investigators will first determine if there are differences between both populations of endogenous cannabinoids, and then determine whether dietary intake of fish oils alters these levels

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Principal Investigator: Michelle Sexton, ND
      • Contact: Michelle Sexton, ND; Phone Number: 206-543-3896; Email: msexton@uw.edu
    • Seattle, Washington, United States, 98028
      • Recruiting
      • University of Washington
      • Contact: Michelle Sexton, ND; Phone Number: 206-538-3896; Email: msexton@uw.edu
      • Principal Investigator: Michelle Sexton, ND

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Multiple Sclerosis

Description

Inclusion Criteria:

Inclusion Criteria for MS patients:

1. Diagnosis of Multiple Sclerosis (relapsing, remitting) made by a clinical neurologist within the previous 5 years by either MRI (> 3 white matter lesions) or score of 3-5 on the Kurtzke Expanded Disability Status Scale.
2. Not currently in "relapse" or exacerbation.
3. Age > 21 and < 50.
4. Subjects must be able to attend study visits at screening, baseline and time points of 4, 12 and 24 weeks.
5. Diet, exercise, and supplementation must be kept constant throughout participation in the study.
6. Ability to read and speak English.

Inclusion criteria for healthy subjects:

1. Current.
2. Age > 21 and < 50.
3. Subjects must be able to attend study visits at screening, baseline and time points 4, 12 and 24 weeks.
4. Diet, exercise, and supplementation must be kept constant throughout participation in the study.
5. Ability to read and speak English.

Exclusion Criteria:

1. Supplementation with fish oils in the last six months.
2. Diagnosis of any bleeding disorder (hemophilia, vonWillebrands, menorrhagia, hypercoaguability, history of clots, thrombocytopenia). Any patient with one of these diagnoses and/or any patient on any of/combination of the following medications would not be eligible for participation: ANTICOAGULANT/ANTIPLATELET DRUGS: Some of these drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin).
3. Hormone Replacement Therapy or oral contraception pills or pregnancy.
4. Use of clinical Cannabis for MS symptom control or recreationally in the last 6 months.
5. Previous diagnosis of DSMV criteria.
6. Use of tobacco, either orally or inhaled.
7. BMI >27 or <19.
8. Diagnosis of Diabetes (fasting blood sugar over 125 mg/dl).
9. Performance athletes.
10. Medical history/diagnosis of autoimmune or other chronic inflammatory disease or serious immunologically-related health condition.
11. Lactose intolerance (in-ability to eat/drink milk products without problems).
12. Allergy to fish or seafood. Theoretically, some people who are allergic to seafood such as fish might also be allergic to fish oil supplements. There is no reliable information showing how likely people with seafood allergy are to have an allergic reaction to fish oils; however, until more is known advise patients allergic to seafood to avoid or use fish oil supplements cautiously.
13. High dose supplement/botanical therapy which may have an effect on bleeding times: Vitamin E (greater than 400 IU/qd); adn/or daily use of any/combination of the following botanical therapy: Angelica sinensis; Allium sativum; Zingiber officinale; Ginkgo biloba; and Salix alba.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
healthy subjects; subjects with no sign of inflammatory disease, or diagnosis of MS
Patients with MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantification of endogenous cannabinoids	one time blood draw

Secondary Outcome Measures

Outcome Measure	Time Frame
Monocyte migration	one time blood draw

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Michelle Sexton, ND, University of Washington

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Estimate): July 13, 2010
• Last Update Submitted That Met QC Criteria: July 9, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Fish Oil; Endocannabinoid; Monocyte Migration
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 35083-B; A50879 (Other Identifier: University of Washington)