Newly diagnosed MS patients needed for clinical trial testing efficacy of diet, lifestyle change

Drawing on her skills as a physician scientist, Terry Wahls, MD, defeated her own symptoms of multiple sclerosis (MS). Now for the first time she is testing whether her method of using a therapeutic diet and lifestyle changes are just as effective at relieving symptoms as disease-modifying medicines. The final preparations for this clinical trial are underway at University of Iowa Health Care for participants to learn these methods virtually.

“The question we’ll be asking with this study is, ‘Can we keep your disease inactive just as effectively with diet, meditation, and exercise as with medication,’” Wahls says. “I get many folks who come up to me and tell me they’ve had great success by embracing my lifestyle program instead of medications, but we’ve never been able to take a newly diagnosed patient and follow them prospectively using my program. This will be the first time.”

“We want to determine how beneficial or harmful it is for participants to decline standard MS medications and use diet and lifestyle changes instead,” she says.

Wahls is recruiting 40 newly diagnosed MS or clinically isolated syndrome patients in a study to compare the effect of a strictly modified diet, meditation, and exercise plan to disease-modifying medications in stabilizing and potentially reducing many of the disease’s symptoms. Participants who have been offered disease-modifying medications and declined them are eligible for the intervention arm. Because Wahls is using a quasi-experimental study design, it is not randomized. Patients who volunteer to be in the intervention arm will be compared to a control arm. If a patient has been newly diagnosed and has declined medication therapy and wants to participate in the study, they will be trained on the study diet, mediation, and exercise protocol virtually and supported by the study team over 12 months. The control group will include 20 individuals being treated by a neurologist with disease-modifying medications while following their usual diet and lifestyle. This group will receive usual care from their medical team and will be followed by the Wahls research team to track disease progression.

Wahls’ team of researchers will collect survey data and assessments to monitor both groups for 12 months, and participants will be asked to share their medical records with the research team. Patients will have the opportunity to participate completely virtually, or when available, will come to the University of Iowa for two visits one year apart.

“This is the first time anyone has prospectively looked at people who turn down the disease-modifying medications and use diet and lifestyle as part of their disease management strategy,” Wahls says. “Imagine what could happen if we show that a therapeutic diet and lifestyle plan is equivalent to medication treatment.”

Because Wahls has a financial interest in the diet and lifestyle plan—she has published three books on “The Wahls Protocol” and has a large national and international following—the university is requiring Wahls follow a strict conflict of interest management plan. An independent statistician has been assigned and will complete the study analyses. Wahls will not have access to data collection or the final data.

Wahls was diagnosed with multiple sclerosis in 2000 and the disease had progressed to the point of requiring a wheelchair to get around. She was concerned with the probability of having to give up her career in medicine and potentially becoming bedridden and living with intractable pain.

Instead, she turned to vitamin supplements and eventually to a complete diet overhaul – combining a functional medicine approach, ancestral medicine and evolutionary biology – and developed what she’s termed “the Wahls Protocol®.” Within a year she was out of the wheelchair, able to walk across the hospital, and completed an 18.5-mile bike ride with her family.

If you are interested in participating in this study, complete the survey to confirm you are eligible using this link https://redcap.icts.uiowa.edu/redcap/surveys/?s=AHHCNKWDYH. You may contact the research team at msdietstudy@healthcare.uiowa.edu or call +1-319-384-5002 to obtain more information about the study.