Sep 1, 2022
Clinical Trial: Efficacy of Diet on Quality of Life in Multiple Sclerosis (EDQ:MS)
ClinicalTrials.gov Identifier: NCT05007483
Type of MS: relapsing-remitting multiple sclerosis (RRMS)
Treatment mode of action: dietary intervention
Number of Participants: 156
Medication: Participants may continue disease-modifying treatments if they are on them
Institution: University of Iowa
Address: 200 Hawkins Drive, Iowa City, Iowa 52242
Contact Name: Mary Ehlinger
Funding: Gift from the Carter Chapman Shreve Family Foundation to the Therapeutic Lifestyle Fund at the University of Iowa
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.
Participants will have a fasting blood draw at each of the study visits and may bring a snack after the blood draw. They will complete assessments of walking, hand, and vision function at each visit. They will have a NON-CONTRAST MRI of the brain at the first and last visits.
Key requirements to participate in the study include the following: 1) be willing to share medical records with the study team, 2) do not have clinically significant heart disease, liver disease, kidney disease or type 1 diabetes, 3) do not have a serious psychiatric disease that would make adopting a study diet more difficult (for example schizophrenia or disabling depression), 4) are not taking insulin, coumadin, or weight loss medications, 5) have a smart phone or tablet to download a free app, and 6) have access to high-speed internet and a computer, tablet or smart phone to complete surveys and participate in video conferences via the Zoom platform.
A screening survey for eligibility to participate in this study is available here: https://redcap.icts.uiowa.edu/redcap/surveys/?s=JX73EYRJNPF9MHRR
Dr. Terry Wahls is an Institute for Functional Medicine Certified Practitioner and a clinical professor of medicine at the University of Iowa where she conducts clinical trials in the setting of Multiple Sclerosis. In 2018 she was awarded the Institute for Functional Medicine’s Linus Pauling Award for her contributions in research, clinical care and patient advocacy. She is the author of The Wahls Protocol: A Radical New Way to Treat All Chronic Autoimmune Conditions Using Paleo Principles, and the cookbook, The Wahls Protocol Cooking for Life. Learn more about her MS clinical trials https://wahls.lab.uiowa.edu/. Pick up a one-page handout for the Wahls™ Diet at https://terrywahls.com/diet/
Wahls Research Lab - to learn about current clinical research studies that Dr. Wahls is conducting
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