Type of MS: RRMS
Treatment mode of action: To improve quality of life and reduce fatigue
Number of Subjects: 156
Medication: dietary intervention
Location: Alabama|Alaska|Arizona|Arkansas|California|Colorado|Connecticut|Delaware|District of Columbia|Florida|Iowa|Kansas|Kentucky|Louisiana|Maine|Maryland|Massachusetts|Michigan|Minnesota|Mississippi|Missouri|Montana|Nebraska|Nevada|New Hampshire|New Jersey|New Mexico|New York|North Carolina|North Dakota|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Vermont|Virginia|Washington|West Virginia|Wisconsin|Wyoming
Institutions: University of Iowa
200 Hawkins Drive
Iowa City, Iowa 52242
Gift from the Carter Chapman Shreve Family Foundation to the Therapeutic Lifestyle Fund at the University of Iowa
Please see below for travel reimbursement information.
This is a research study comparing the effects of three diets — a Modified Paleolithic Diet (elimination of gluten, dairy, and eggs), a Time Restricted Olive Oil-based Ketogenic diet, and usual diet with information about the USDA Dietary Guidelines for Americans — to determine whether these diets improve quality of life and reduce fatigue, a disabling symptom that can significantly interfere with the ability to function in daily life. Participants in the usual diet group will be encouraged but not required to follow the Dietary Guidelines for Americans diet. The study will also measure the impact of the study diets on walking function, hand function, vision, serum neurofilament (blood biomarker), and brain imaging (presence of enhancing lesions and changes in brain volume).
The study will be held at the University of Iowa Hospitals & Clinics over two years. It will consist of three visits to Iowa City, Iowa. The first visit occurs at month 0. The second visit is at month 3, and third and final visit is at month 24. The first visit may last 4-6 hours. The second visit will last about 2-3 hour. The third visit may last approximately 4-6 hours.
Participants will be randomly assigned to follow one of the three study diets. Participants will continue to take their current medications, including any disease-modifying treatments for multiple sclerosis. Participants may take recommended supplements, eat more non-starchy vegetables, complete daily food logs (3 questions) on a free smartphone application, complete online surveys every three months, watch videos to learn about the study diet to which they are assigned, meet with the study dietitian to learn about the study diet to which they are assigned, and attend optional online support meetings. If a participant is assigned to the ketogenic diet, they will be asked to take a blood ketone measurement using a drop of blood daily for the first month, then twice per week. They will have a device that pricks the finger to conduct the blood ketone measurement.
TRAVEL REIMBURSEMENT INFORMATION
Study participants that live greater than 500 miles will have additional costs associated with travel expenses due to reimbursement restrictions. We can offer a travel stipend to support some of these expenses to and from Iowa City. Mileage reimbursement will be paid up to 1000 miles roundtrip according to the IRS reimbursement rate for medical visits. We also offer compensation to participants after they come to the site for their time and to offset some of these costs.
If you will travel more than 100 miles to the study visit (200 miles round trip), you can be reimbursed for one night of lodging per study visit according to the published IRS hotel reimbursement rate if you provide us with an itemized hotel/motel bill/folio. Lodging reimbursement is limited to the actual/reasonable cost of a single room plus applicable taxes with a maximum rate of $96.00. Travelers are encouraged to ask for the discounted rate and inquire about free shuttles to the hospital when making reservations (i.e., the government/educational/corporate rate). We will provide you with a list of local hotels and motels.”