Ultimate MS Diet Throwdown: Wahls vs Swank

[ActiveMSers]

So the MS Society is putting up ten $100,000 Bars (that would be $1 million) to study two popular MS diets and their effect on fatigue over 24 weeks. While some might argue with the length of the study (a total of 36 weeks), a near half year hopefully will be enough time to illuminate trends, if any. And some might argue about Dr. Wahls leading the study, who stands to profit from any positive results. And then some might argue that they should be looking at primary benefits other than fatigue.

But ultimately there's another big problem with the study: there is no diet control. By that, I, and many others, am of the opinion that a healthy diet is good for MS. And that eating better and losing weight will lead to less fatigue. This makes brilliant common sense. That would by my hypothesis for this study. So why wasn't a common sense, popular diet included as a control?

I predict this is what is going to happen: Both diets will lower fatigue a bit, and both will be hailed as successful MS diets. Balderdash. Since no other diet was included, MSers will conclude that only Wahls and Swank diets work, even though I'd wager that less restrictive and easier to follow diets (like the Mediterranean Diet) would have similar effects. As it is, when this study wraps up, sales of books by Wahls and Swank will rise and our knowledge of MS diets will grow infinitesimally. Beyond disappointing.

The results from the study won't be released until 2020. I won't be holding my breath. - D


------------------

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

August 24, 2016

Summary The National MS Society has just committed over $1 million to support a clinical trial led by Dr. Terry Wahls to compare the ability of two popular diets to treat MS-related fatigue.

The award helps advance the Society’s Wellness research goals to help people know what they can do today to feel their best, and whether lifestyle interventions can impact the course of MS.

This financial commitment is the latest in the Society’s relentless research efforts to move us closer to a world free of MS, and part of a projected investment of $50 million in 2016 alone to support more than 380 new and ongoing studies around the world.
This trial is recruiting participants with relapsing-remitting MS who experience fatigue, and who live within a 500-mile radius of Iowa City, IA. See below for details about participating and Frequently Asked Questions about the study.

Details

The National MS Society has just committed over $1 million to support a clinical trial at the University of Iowa led by Terry Wahls, MD, to compare the ability of 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. This financial commitment is the latest in the Society’s relentless research efforts to move us closer to a world free of MS, and 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.

“Together with the National MS Society, and this grant, we will be able to take our long-standing work even further, examining how food and nutrients can impact the lives of people with multiple sclerosis,” said Dr. Wahls.

Background: 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. 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 possibly other symptoms commonly experienced by people living with MS.

Terry Wahls, MD, created the Wahls Protocol diet after being diagnosed with MS herself. She’s spent more than a decade studying the origins of certain foods and vitamins and their effects on the body. The Wahls Protocol follows 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.

Roy Swank, MD, PhD, began studying MS in 1948. He 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 where people 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.

The Study: 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.

This study is currently recruiting participants. Participants must live within a 500-mile radius of Iowa City, IA. This includes the states of Iowa, Illinois, Indiana, Missouri, and Wisconsin, and parts of Arkansas, Kansas, Kentucky, Michigan, Minnesota, Nebraska, North Dakota, Ohio, Oklahoma, and Tennessee. Individuals interested in being considered for enrollment in this study may complete screening questionnaires at this link and use code: JMJPYEJHP. For questions, please email MSDietStudy@healthcare.uiowa.edu or call 319-384-5053.

[ActiveMSers]

The MS Society also included an FAQ.

-----------------

Frequently Asked Questions: New Clinical Trial of Dietary Approaches to Treating MS Fatigue

Q. Why is the National MS Society investing research money in diet studies?
A. 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 trial takes a carefully designed approach to understanding the potential impact of two widely used MS-related diets on fatigue and potentially other symptoms commonly experienced by people living with MS.

Q. Why is the Society giving money to Dr. Wahls, who is already profiting from the promotion of her diet?
A. First, when the Society makes a research grant, the funds associated with the grant go to the investigator’s institution – the University of Iowa – and are administered by the university, not the investigator. Second, as with any clinical trial that the Society supports, the trial was carefully reviewed by independent scientific experts. They assessed the trial for both its scientific rigor, but also looked closely at the design to ensure there were no biases that might influence outcomes or interpretation of the results. Third, the funding agreement between the Society and the University of Iowa has strict provisions to ensure compliance with conflict of interest policies including disclosure of conflicts and issues surrounding monetary rewards or other tangible benefits derived from this research. For ongoing assurances, the Society is appointing a data and safety monitoring board to monitor safety of participants and to oversee implementation of the study to ensure it complies with best practices for scientific validity and objectivity, as well as adherence to the study protocol. Lastly, the agreement with the University prohibits use of the Society’s name, logo or trademarks to promote any activity, product, or enterprise without the express written permission of the Society.

Q. What is this clinical trial testing?
A. This trial is comparing the ability of two different dietary approaches to reduce MS-related fatigue. Participants will be randomly assigned to follow a low saturated fat diet (Swank diet) or a modified paleolithic diet (Wahls diet), along with specific nutritional supplements, and will keep careful food diaries. Their health and activities, particularly physical activity level, will be extensively monitored before and during the study. The trial will last 36 weeks.

Q. What is the low saturated fat (Swank) diet?
A. The Swank diet, developed by the late Dr. Roy Swank, limits intake of saturated and unsaturated fats and oils, eliminates processed foods containing saturated fats, eliminates red meat for the first year, and includes eating fruits and vegetables, nonfat dairy products as well as whole grain cereals and pastas.

Q. What is the modified paleolithic (Wahls) diet?
A. The paleolithic diet involves eating natural foods while avoiding highly processed food, especially high carbohydrate foods that significantly raise blood sugar; and also emphasizes the intake of game (non-domesticated) meats and plant-based foods (fruits, roots, and nuts). The modified paleolithic (Wahls) diet also eliminates foods to which some individuals may be sensitive, including grains, dairy, legumes (including soy), eggs, and nightshades (tomatoes, potatoes, eggplant and peppers), but continues to stress a high intake of vegetables.

Q. How long will it take before the results of this trial are available?
A. About four years. Clinical trials generally take many months to establish processes, convene a safety monitoring committee and to recruit all participants. Once it has begun, the actual study takes 36 weeks for each individual enrolled. The results can only be evaluated after all participants have completed all testing involved in the study, and then it usually takes months to evaluate the results, write a paper describing the results, and then getting it published in a peer-reviewed medical journal. Given this, it is likely that study results will be released in 2020.

Q. Besides fatigue, what other impacts are being tracked during the trial?
A. Participants will be monitored to track their physical activity, nutritional status, mobility, cognition, and mood, and will also be monitored for potential side effects.

Q. Are there any potential side effects or risks associated with these diets?
A. Yes. Some restrictive diets may lead to vitamin or mineral deficiencies, which may impact overall health. The paleo diet can result in deficiencies in folic acid, thiamine and vitamin B6 (due to reduced intake of cereals), calcium and vitamin D (due to lack of dairy intake) and insufficient caloric intake without appropriate nutritional advice. Although no definite deficiencies would be expected to develop from the Swank diet, a recent study showed that people following this diet were consuming less than the recommended levels of vitamin A, C, E and folate. For these reasons, this clinical trial includes nutritional supplements for all participants and careful monitoring of potential side effects.

Q. How do I find out whether I am eligible to participate in this trial?
A. There are specific criteria established for determining who is eligible. People with relapsing-remitting MS who are experiencing fatigue and live within 500 miles of Iowa City will be considered for enrollment. Individuals who wish to be considered may complete a screening questionnaire 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.

Q. Can a potential study participant be on an MS disease-modifying therapy?
A. Yes. Enrolled participants will be asked to continue their usual medications during the study, and also to maintain their usual physical activities and stress reduction regimens, unless their physician or physical therapist recommends changes.

Q. I have progressive MS. Why isn’t the trial including people with progressive MS?
A. The decision to include only individuals with relapsing-remitting MS was made after careful consideration. One reason is that many studies have difficulty recruiting enough participants, and since there are more people who have relapsing-remitting MS than who have specific forms of progressive MS, the study is more likely to achieve its recruitment goals. Another reason is that including both relapsing-remitting and progressive participants would require recruitment of many more people, since the analysis of the results would have to make provisions for examining possible differences in the response of relapsing versus progressive participants. This would raise the cost of the study beyond what is feasible.

Q. I have MS and I don’t live near Iowa. Is there any reason why I shouldn’t try one of these diets on my own?
A. Unless you have an allergy or medical condition that would prohibit any of the foods suggested for these diets, there’s no reason not to try one of these diets. However it is a good idea to check with your healthcare provider before undertaking any major change in your dietary habits. Also, be sure to get the full details about these diets and their recommended nutritional supplements so that you get the nutrition you need while you are trying one of these approaches.

Q. What diet is recommended for people with MS?
A. Although there’s no proven “MS diet,” what and how you eat can make a difference in your energy level, bladder and bowel function, and overall health. MS specialists recommend that people with MS adhere to the same low-fat, high-fiber diet recommendations of the American Heart Association and the American Cancer Society for the general population.

Q. What other dietary approaches are being tested in MS?
A. The National MS Society is supporting several clinical trials including one exploring the impacts of intermittent calorie restriction (at Johns Hopkins University in Baltimore, currently recruiting participants), and a medical food for the treatment of MS cognitive impairment (at the University of Miami, currently recruiting participants). Other trials include a study investigating the impact of dietary salt on immune function (at Yale University, New Haven, currently recruiting participants).

[cl3me]

I would like to know how precisely they will be "measuring" fatigue; if it's a self reported survey this clinical trial is junk because it could end up just being placebo effect. This is a lot of money to only be looking at fatigue outcomes so they had better be doing it in an objective manner! I also agree Dave, this trial is missing a control/no intervention.

[michraf]

What a friggin waste!

why not spend the 1 million on something useful.
The Tisch MS Research center was denied a grant for their FDA approved stem cell study. I'm sorry, but the NMSS really pisses me off.

[Marinadca]

why not spend the 1 million on something useful.
The Tisch MS Research center was denied a grant for their FDA approved stem cell study. I'm sorry, but the NMSS really pisses me off.

I have to agree that this seems like a waste of money. Eat healthy, follow a diet if it makes you feel better, what's to study? Healthy diet = better health no matter is you have MS or not. Try things out and go with what works for you.

I can see many better place 1 Million bucks can go.

[Suebee]

I would have liked the money put into a pot for small grants for active msers who want to stay active and in the workforce. For example, $3k to get a person certified as a teacher or to take classes toward a new trade/professional license; to get an ipad that helps with managing tasks; a fancy set of walking sticks; or a trike! Wouldn't that help MSers more directly and long term than this study? Disappointing.

[Professor]

So the MS Society is putting up ten $100,000 Bars (that would be $1 million) to study two popular MS diets and their effect on fatigue over 24 weeks. While some might argue with the length of the study (a total of 36 weeks), a near half year hopefully will be enough time to illuminate trends, if any. And some might argue about Dr. Wahls leading the study, who stands to profit from any positive results. And then some might argue that they should be looking at primary benefits other than fatigue.

But ultimately there's another big problem with the study: there is no diet control. By that, I, and many others, am of the opinion that a healthy diet is good for MS. And that eating better and losing weight will lead to less fatigue. This makes brilliant common sense. That would by my hypothesis for this study. So why wasn't a common sense, popular diet included as a control?

I predict this is what is going to happen: Both diets will lower fatigue a bit, and both will be hailed as successful MS diets. Balderdash. Since no other diet was included, MSers will conclude that only Wahls and Swank diets work, even though I'd wager that less restrictive and easier to follow diets (like the Mediterranean Diet) would have similar effects. As it is, when this study wraps up, sales of books by Wahls and Swank will rise and our knowledge of MS diets will grow infinitesimally. Beyond disappointing.

I am a professor who teaches clinical nutrition. It amazes me how many "scientific" studies published in respected journals do not follow basic research principles. It seems that many present-day scientists have either forgotten or just don't care about the scientific method. I've seen terribly designed studies published in top journals. Peer review has become a joke.

It would cost very little - if any - more to include a control group and then the study wouldn't be a waste of money.

[AMFADVENTURES]

Hey Dave, where did this information come from anyway??? It would be interesting to see the actual study proposal. It does beg the question of what criteria NMSS uses to distribute grant money for scientific studies, a question I would be more than happy to ask NMSS, assuming there isn't a representative on the forums here that would be willing to answer it.

Along those lines, I would like to say that I have found NMSS willing to listen and even re-evaluate policy based on what we as MSers have to say. I'll give you an example.

I recently had an opportunity to talk at length with the NMSS president of our local chapter concerning how disappointed I was that Rituxan was not covered on the NMSS Web site. I pointed out that about half of the people present at the time, including myself, were on Rituxan and that it was covered by SSDI, Medicare, Medicaid and the Veteran's administration as well as a few insurance companies. I explained that Rituxan was commonly prescribed in our area by the Rocky Mountain MS Clinic, one of the most respected in the nation, as well as others, and that there had been several large, favorable studies presented at the most recent ECTRIMS on it. That it had been through phase II of the FDA approval process and that statistics on the drug for people with RR and SP MS were no less impressive than its twin, Ocrelizumab, currently undergoing fast track FDA approval. That Rituxan was a fraction of the cost of any of the newer drugs and certainly the expected cost of Ocrelizumab. At one point an assistant pointed out that Rituxan was not an FDA approved therapy for MS to which I pointed out that neither was marijuana and that in fact, marijuana was largely untested and still illegal at the federal level, yet NMSS had a lengthy discussion of it on their Web site. I went on to point out that there likely would never be a phase III FDA trial performed on Rituxan as the patent on the drug had expired, making it an unrewarding expenditure. Finally I mentioned that the omission of Rituxan on NMSS's Web site was obviously not in the best interests of PWMS and could easily be construed as manipulation of the NMSS by big pharma.

The chapter president simply said that she was unaware of any of this, and that she would check into it and find out what was going on.

About two weeks later she called me to say she she had talked to NMSS and that they did in fact say the Rituxan omission was their policy regarding non FDA approved therapies. BUT, that she pursued the issue, mentioning most of the points I had raised, including the marijuana, until she finally got someone to say that they would review their decision concerning listing Rituxan on the Web site.

It is timely now because I just received a survey request from NMSS regarding MS therapies. Rituxan was one of the listed therapy choices. So I am hopeful that this may have had something to do with our local chapter president's discussion with National NMSS and will eventually lead to a more thorough DMT list on the NMSS website.

The moral of the story is, Talk to Them if you are really interested in effecting change.

[ActiveMSers]

The Des Moines Register asked a few of the same questions, and other researchers are also skeptical. The right questions were asked in the study planning process, and they were summarily dismissed.

I'll write the NMSS, but I fear that ship has sailed. They are heavily promoting their participation in the trial and have even released a set of talking points, which I included below.

The study also ignores the ultimate "promise" of these diets: that they can reverse your MS without drugs, including progressive MS. Yet they are only studying RRMS, presumably many of the patients on medication. How do you accurately compare someone on Copaxone with someone taking Lemtrada?

I still just don't get it. I feel it's important to study diet in MS, but this misses the mark on so many level. - D

----------------

But a national ethics expert said it would have been better to hire an outside researcher to lead the study. Having that position filled by the diet’s main promoter “raises an eyebrow,” said Arthur Caplan, a bio-ethics professor at New York University.

Even legitimate, positive results of the study could be met with skepticism because of Wahls’ role, Caplan said. “If you wanted to do the best job with your million dollars, you could hire somebody who’s independent,” he said of the National MS Society’s grant. ...

Unlike many other research projects, this one will not have a control group of patients who continue their normal routines throughout the study. That omission surprised Caplan...

Wahls and LaRocca said they discussed having a control group, but decided it would be difficult to recruit and retain volunteer patients for the study if they weren’t going to be asked to do anything different from their regular routines.

http://www.desmoinesregister.com/sto...orks/89343218/

----------------------

Talking Points Regarding National MS Society & University of Iowa Diet Study

* This is the first big diet study the National MS Society has supported and we are excited to be teaming up with the University of Iowa.

* The Society is committing more than $1 million to support a clinical trial led by Dr. Terry Wahls at the University of Iowa. The study will compare the ability of two popular diets to treat MS-related fatigue.

* Fatigue is one of the most common symptoms of MS, occurring in about 80 percent of people, so you can see there’s a great need for this kind of research.

* This is a major investment in the Society’s Wellness research goal. We want to help people living with MS know what they can do today to feel their best, and whether lifestyle interventions can impact the course of MS.

* This trial is recruiting participants with relapsing-remitting MS who experience fatigue. The participants must live within a 500-mile radius of Iowa City, IA.

* Individuals who wish to be considered may complete a screening questionnaire 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.

[amc5827]

Did anyone else see where they said that they didn't do a control group because they were afraid people wouldn't sign up? You mean, they think that people wouldn't be interested in helping get more information about their disease by doing nothing but showing up occasionally and maybe doing a survey?

It sounds to me like they are worried that the results won't be statistically significant. At which point, the person running the experiment won't be able to promote her own diet. even if it does show something, the results are still tainted by having no control group.

What a waste of a million dollars. If they want to waste that much money, I can sure help with that!

[ActiveMSers]

amc, there are many ways to organize a control group, and I am confident volunteers would have been willing to step up and wait a few months longer to begin a diet. The study designers should give us MSers more credit.

But I gotta hand it to Dr. Wahls. It's not every day seven figures drops in your lap to promote and legitimize your own diet. For her, the study design is pretty much ideal with essentially guaranteed success. Can't blame her.

I also find the NMSS position of costs preventing a more thorough and robust study a bit dubious. As it is, they appear just to be giving lip service to those who want diets studied. I want them studied, but I want them studied properly. They should have waited until the funds were available to do it right.

[ActiveMSers]

I've written the NMSS. We'll see what they say. The just released study (link below) that shows a Mediterranean diet, plus exercise, lowers fatigue in MSers underscores my concerns. Any decent diet should help lower fatigue.

http://forums.activemsers.org/showthread.php?t=2206

[funnybutnotfunny]

Bogus.

I personally like the Forks Over Knives way, but I still eat certain meats about 5% of the time if they are cage free, hormone free, organic, etc.

I agree with you about the Mediterranean.

Everyone can benefit from a common sense whole foods sort of a diet, not just those with chronic health conditions.

I don't understand why they are wasting donor $ on this study. It's obvious that it will be biased.