Recruiting

Immune Markers

Sponsor:

University of Washington

Code:

NCT01026272

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Multiple Sclerosis

Study ID

NCT01026272

Start date

Jan, 2010

Status verified date

Jul, 2010

Completion date

May, 2011

Anticipated

Primary completion date

Jan, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

healthy subjects

subjects with no sign of inflammatory disease, or diagnosis of MS

Patients with MS

Primary outcome measure

  • Quantification of endogenous cannabinoids [ Time Frame: one time blood draw ]

Central Contacts and Locations

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98028

Contacts

Michelle Sexton, ND

206-538-3896msexton@uw.edu

Principal Investigator:

Michelle Sexton, ND

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Michelle Sexton, ND

206-543-3896msexton@uw.edu

Principal Investigator:

Michelle Sexton, ND

More Information

Sponsor

University of Washington

Last update posted

Jul 13, 2010

Last verified

Jul, 2010

Keywords

  • Endocannabinoid
  • Fish Oil
  • Multiple Sclerosis
  • Monocyte Migration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2010-07-13.