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National MS Society and University of Iowa Launch $1 Million Clinical Trial to Test Dietary Approaches to Treating Fatigue in Multiple Sclerosis

Date: Monday, August 29, 2016

Terry Wahls knows first-hand what the right diet can do for a person’s health and well-being; her own diet, the Wahls Protocol, helped her combat the fatigue and physical symptoms of multiple sclerosis (MS) nearly 10 years ago. At the time, Wahls, a University of Iowa professor of internal medicine, was confined to a wheelchair and her own MS was advancing.

The Wahls Protocol – a special diet and supplement regimen based on a Paleolithic diet – led to a dramatic improvement in her mobility. 

“In three months the fatigue was gone,” she says today. “In six months I was walking without a cane, and after nine months I was biking around the block. A year after I started, I did a 20-mile bike ride.”

Hers wasn’t the first diet designed to minimize the physical symptoms of MS; Roy Swank, MD, PhD, began studying MS in 1948 and created the low saturated fat Swank Diet around 1950.

Now, the National Multiple Sclerosis Society (NMSS) wants Wahls to compare the two diets.

Wahls, MD, has been awarded a $1 million grant from the NMSS to compare the ability of the two popular diets to treat multiple sclerosis-related fatigue, a disabling symptom that can significantly interfere with a person’s ability to function at home and work. 

The grant is one of the largest financial commitments made by the NMSS to research this year, and is part of a projected investment of $50 million in 2016 alone to support more than 380 new and ongoing studies around the world aimed at stopping the disease in its tracks, restoring function, and ultimately ending MS forever.

“The National MS Society is committed to identifying wellness solutions to help people live their best lives,” noted Bruce Bebo, PhD, the Society’s Executive Vice President, Research. “We’re very pleased to support a rigorous clinical trial to test the ability of two popular MS dietary approaches to address the disabling symptom of fatigue,” he added. 

Wellness – and the strategies needed to achieve it – is a high priority for people living with MS and for National MS Society programs and research. For the most part, research studies in the area of dietary approaches have generally been of inadequate size and design to provide useful information about dietary strategies in MS. This new trial takes a carefully designed approach to understanding the potential impact of diet on fatigue and potentially other symptoms commonly experienced by people living with MS. 

Wahls has been studying the effects of diet on MS for more than a decade. She was personally diagnosed with MS in 2000, and by 2003 the disease had progressed so much that she was confined to a wheelchair and feared she would be bedridden. In 2004, she says, she returned to her basic science roots and spent the next three years researching origins of food and vitamins and their effects on the body.

In the fall of 2007, Wahls put her new paleo protocol to use, using herself as the only trial participant. Her protocol is a modified Paleolithic diet that doesn’t include grains, eggs, dairy products, legumes, and nightshade vegetables, but places a heavy emphasis on vegetables, fruit, meat, and fish.
Within months, her fatigue was gone and she started walking again, and then riding a bicycle.

Wahls worked with other University of Iowa researchers to write up a case study of her own results, which was published in 2009. 

“Our work has progressed from the initial case study describing the use of diet, exercise, and electrical stimulation in the setting of secondary progressive MS, to a small pilot study using the same protocol that I used for my recovery in others with progressive MS which was published in 2014. We saw the protocol was associated with remarkable improvement in function, in others with progressive MS,” she says now.

“We were able to show that the program was well tolerated and was associated with clinically and statistically significant reduction in fatigue and improved quality of life,” Wahls says.

For the new study, investigators will be recruiting 100 people with relapsing-remitting MS who experience fatigue to enroll in the 36-week clinical trial. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow a low saturated fat diet (Swank diet) or a modified paleolithic diet (Wahls diet), for 24 weeks. Their health and activities will be extensively monitored during the study. 

Swank, began studying MS in 1948 and created the low saturated fat Swank Diet around 1950 after he observed a higher incidence of MS in geographic areas where people ate meat, milk, eggs, and cheese – foods that are high in saturated fat -- and a lower incidence in areas that ate fish. He spent more than 50 years recommending this diet to his patients and monitoring their health.

Both diets have been shown to have a positive impact on patients with multiple sclerosis.

Individuals interested in being considered for enrollment in this study may complete screening questionnaires at https://redcap.icts.uiowa.edu/redcap/surveys/ and use code: JMJPYEJHP. For questions, please email MSDietStudy@healthcare.uiowa.edu or call 319-384-5053.


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