Most recently, in collaboration with the University of Pennsylvania's Scheie Eye Institute, we submitted a Stimulus Challenge Grant proposal on April 27, 2009 to the National Institutes of Health (NIH.) This study, if and when approved, will begin in October 2009.
The objective is to investigate the effects of a high nutrient density (HND) diet in patients with advanced age-related Macular Degeneration (AMD), which is the leading cause of severe vision loss in people 50 years and older. Thedesign includes a prospective cohort study of 50 patients, men and women ages 55 years and older, with a diverse demographic. Adherence will be measured with food diaries and serum carotenoid levels.
The primary endpoints will include serum inflammatory indices, such as high sensitivity C-reactive protein. The secondary endpoints involve visual acuity and the frequency of current standard of care drug injections. The trial will take two years to complete. There is precedent demonstrating the benefits of green leafy vegetables in the Eye Disease Case Control Study on AMD patients. The results showed an AMD risk reduction of 43%.
Another project is a case series involving ten patients with type II diabetes. This trial is also in collaboration with the University of Pennsylvania. Diabetes is a disease that continues to increase in prevalence, and there is a significantand immediate need for lifestyle changes that work. In 2005, it was estimated that 20.8 million people had diabetes in the U.S. In only 2 years, the estimate has increased to 23.6 million, and diabetes is the 7th leading cause of death in the U.S., according to the National Diabetes Information Clearinghouse.
This is why it is so important that the Eat Right America Foundation is working on the retrospective case series. The design of the trial involves reviewing patient's charts and laboratory data and contacting the participants about qualitative aspects of the disease. The data is currently being analyzed and the paper is the process of being written.
The preliminary results look quite impressive, both from an efficacy perspective and from a compliance one. Most of these patients have co-morbidities, such as hypertension and high cholesterol. Fortunately, early data shows improvements in these co-morbidities. Though this study is small, hopefully the impact will be dramatic. We are enthusiastic about the paper and should be submitting the study for publication in a medical journal shortly. The goal is that this pilot study will lead to a large clinical trial. Meetings and planning for this trial are already underway with the endocrinology department at the University of Pennsylvania.
A pilot study investigating the experience of hunger and dietary habits is about to begin. The study, Changing Our Understanding of Hunger Signals, will look closely at how we perceive hunger and document variations depending on the type of diet we eat.
We know that many components of an unhealthy diet have addictive qualities; and like any addictive substance, when we don't ingest them we experience uncomfortable withdrawal symptoms. Researchers postulate that these withdrawal symptoms have long been inaccurately mistaken for hunger. Like hunger, these uncomfortable sensations are relieved by eating and, as such, lead to overeating and weight gain.
Dr. Fuhrman postulates that our perceptions of hunger, both physical and psychological,are dramatically different depending on the amount of addictive and unhealthy food in our diet. The term 'toxic hunger' has been used by Dr. Fuhrman to describe this phenomenon.
This important study has the potential to bring into sharp focus why some people overeat in the absence of a physiological caloric need. This is truly ground-breaking research and the information gleaned from it could completely change how we view hunger.
We have started working on several other retrospective case series involving chart reviews. These topics include migraines, heart disease, vascular disease, hepatitis C and autoimmune diseases, such as rheumatoid arthritis, lupus, multiple sclerosis and psoriasis.