2017 has been a tremendous year for our research team, and we are looking forward to the progress that 2018 will bring. Here are a few highlights from over the last year (progress update as of 12/01/17):
Current Clinical Trial: Dietary Approaches to Treating MS Related Fatigue
This current study is funded by a $1 million grant from the National MS Society to compare the effectiveness of a low-saturated fat diet (Swank) and the modified Paleolithic diet (Wahls Elimination) at reducing the severity of MS-related fatigue.
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 MS. In addition to the National MS Society grant, private support has allowed her team of investigators to collect data, and they have added expanded mechanistic studies to the clinical trial.
- A total of 41 individuals are now enrolled and consented in the Swank vs. Wahls clinical study and recruitment has gone better than anticipated with 41 participants enrolled.
- 17/41 have completed the full study; long-term follow-up for all of these individuals will take place throughout the 3-year trial to track any significant sustained change.
- Since enrollment began, only 5 individuals had to drop out of the study; which is better than the average for clinical trials in any area of medicine.
- Microbiome samples (4 per subject) have been collected and the DNA extracted.
- Also collecting microbiome samples from a healthy control group.
- Private philanthropy has supported mechanistic studies of the microbiome and vision function of participants. Further private support is required to analyze the fecal samples post dietary intervention, and identify change in bacterial diversity. Completing this analysis and its findings will set the stage for larger grant support in analyzing the microbiome as it relates to the setting of MS as well as other inflammatory diseases.
Wahls vs. Swank Menu Analysis
- Studying the nutritional adequacy of both diets in their “ideal” state within the recommended daily allowance (not how they may be consumed in real life).
- Using statistical analysis and standard research protocol to compare the nutrient intake of the two diets. No one else is looking at therapeutic diet in terms of scientific nutritional adequacy.
- Will result in a landmark paper projected for publication in 2018.
- Working with Ruth Grossman (University of Iowa College of Public Health), this study focuses on tracking changes in healthy individuals on standard American diet vs. the Wahls diet
- Collecting blood, urine and stool for future analyses and the healthy control for the Wahls diet.
- Thoroughly describes what the intervention is and how it works.
- Focuses on the dietary aspects and provides a precise scientific description of the Wahls Elimination diet. This will also be published in 2018 by the investigators and the MS Society.
Vision Study in MS Patients
- Advanced vision study exploring whether re-myelination in the optic nerve pathways is possible using the Wahls Elimination dietary intervention. The study would randomize participants that have abnormal conduction due to MS or optic neuritis.
Wahls Diet vs. Usual Care
The goal of this project is to compare a diet only treatment to usual care in the setting of newly diagnosed relapsing remitting multiple sclerosis or clinically isolated syndrome on the annual relapse rate, motor function and visual function and quality of life and brain structure as measured by MRI. The study question is whether a diet only treatment is as effective as usual care in reducing disease activity, stabilizing and clinical function, improving quality of life, and the impact on brain structure in newly diagnosed patients.
Dietary Approaches to Treating ALS Related Symptoms
Anecdotal favorable response in an ALS patient who utilized this diet has been observed. The primary focus is to measure changes in weight and body composition over the duration of the study. Additionally, effects of the study diet on muscle and respiratory functions, blood biomarkers, quality of life, care giver burden and diet quality via three 24-hour dietary recalls will be measured. After baseline tests are obtained, the participant and significant other will eat a sample meal and be trained on the diet by the study Registered Dietitian (RD) who will then call the participant weekly to provide support. The subject will receive a high-powered blender for use during the study to make high-caloric smoothies and shakes, and be coached by the RD on strategies to increase calorie and protein intake. The participant will return at 6 weeks to complete another body composition assessment. If muscle mass has decreased, the study neurologist will determine whether the participant should resume their usual diet. The RD will coach the participant on additional strategies to increase calories and protein intake if weight loss is observed. The participant will return for the end-of-study visit at 12 weeks and all assessments will be repeated.
Nutritional status is a strong predictor of clinical outcomes in ALS patients; however dietary intervention studies have been stopped due to excess weight loss. Several nutritional markers such as increases in fat mass, declines in fat-free mass and a high extracellular water/intracellular water ratio over time are associated with a shorter time to death. Bio-electrical impedance spectroscopy (BIS) assesses these markers and is a useful tool in monitoring nutritional factors contributing to clinical outcomes. Based on our clinical experience and our unpublished research data from an initial study of progressive MS patients showing improvements in energy and quality of life, we anticipate a modified Paleolithic diet may also be beneficial for ALS patients. BIS allows us to closely monitor changes in body composition to assess the safety of the study diet in ALS patients.
Thank you to all that have believed and invested in our work—it is because of your generosity that we are able to explore this ground-breaking research. I wish for you strength of mind, body and heart in the New Year!
-Terry Wahls, M.D.
For more more information on donating to The Wahls Research Fund visit this link.