Apr 08, 2011
Summary:Investigators at Oregon Health & Science University are recruiting 54 people with relapsing-remitting MS for a study comparing the effectiveness of a low-fat diet program versus no intervention in controlling disease activity in MS. Please note: The study requires six clinic visits to Portland, Oregon, and a 10-day visit for diet training to Santa Rosa, California. Travel costs are covered by the study.
Rationale: Maintenance of general good health is very important for persons with MS or any chronic disorder. A well-balanced and carefully planned diet will help to achieve this goal. MS specialists recommend that people with MS adhere to the same low-fat, high-fiber diet that is recommended for the general population. While different diets have been proposed as a treatment for the signs and symptoms of MS, none have been proven to do so in rigorous, controlled studies. This study is seeking to determine the effectiveness of the McDougall Program – a low-fat, plant-based diet – on controlling disease activity in MS.
Eligibility and Details:Researchers are recruiting people with relapsing-remitting MS, ages 18 through 70, who have had MS for less than 15 years. They may or may not be on disease-modifying therapies for MS, but if on, must have been treated for more than 6 months of continuous therapy. Participants should be able and willing to travel to Santa Rosa, California for the 10-day training program and to Portland, Oregon for six study visits over the 12-month study period; travel costs are covered by the study. Those receiving the diet training will be expected to adhere to the diet for the one-year duration of the trial. Further details about the enrollment criteria are available from the contact below.
Participants will be randomly assigned to receive low-fat diet training (a 10-day program at the McDougall Center in Santa Rosa, California) and be followed for 12 months on the diet, or no diet training and 12 months of follow up. The primary outcome being measured is new disease activity observed on MRI scans. Secondary outcomes being measured are relapse rate; clinical measures of disability progression, fatigue, depression and quality of life; the effects on markers of inflammation in the blood; and safety and tolerability.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Courtney Zerizef at 503-494-0174 or zerizefc@ohsu.edu. (Principal Investigator: Vijayshree Yadav. OHSU IRB # 4555)