Nutrition Science Initiative (NuSI) has launched the first-ever randomized, controlled clinical trial to determine whether removing added sugars from the diet can halt or even reverse nonalcoholic fatty liver disease (NAFLD) in children.
Once considered a disease of adults and virtually unheard of in children, the prevalence of NAFLD in adolescents has become increasingly rampant with one in 10 children in the United States—more than 7 million—afflicted with the condition, according to recent estimates from the Centers for Disease Control and Prevention. A rapidly growing epidemic, forty million adults in America also suffer from NAFLD, which is now recognized as the most common form of liver disease in the Western world.
In December 2014, NuSI kicked off a matching-gift campaign to fund the pilot NAFLD study and raised almost $1.5 million within months after an overwhelming response from the public, several generous philanthropists, and a $1 million grant from the Laura and John Arnold Foundation.
NAFLD is characterized by increased fat deposits in the liver known as hepatic steatosis. If left unchecked, the excess fat buildup can lead to serious health problems, including inflammation and fibrosis in the liver, and eventually advance to cirrhosis. By the time it reaches that point, the disease—referred to as nonalcoholic steatohepatitis, or NASH—may be irreversible and ultimately can result in liver failure or a deadly type of liver cancer known as hepatocellular carcinoma. Currently, there are no safe or effective drugs recommended to treat children or adults with NAFLD.
The NuSI funded study will be a collaborative effort led by principal investigators Dr. Miriam Vos, associate professor of pediatrics at Emory University School of Medicine and a pediatric hepatologist at Children's Healthcare of Atlanta, and Dr. Jeffrey Schwimmer, professor of clinical pediatrics at University of California, San Diego School of Medicine and director of the Weight and Wellness Center and the Fatty Liver Clinic at Rady Children's Hospital-San Diego.
"NAFLD is the most common cause of chronic liver disease in children, yet there is great controversy over the role of dietary fat versus dietary sugar versus calories in general," Schwimmer said. "There is a growing body of indirect evidence that supports the importance of sugar as a potential cause or contributor to fatty liver. Studies like this one are needed to be able to provide the best nutritional recommendations to the millions of children with NAFLD in the U.S."
The study will serve to develop an understanding of the potential of a low "free sugars" diet for the treatment of NAFLD in children. Forty children with NAFLD will be assigned to either an intervention group or a habitual diet control group. The study team will visit the families' homes in order to learn about their current ways of eating. In the intervention group, the study team will provide the families with a similar version of their current diet, with the exception of assuring that it is low in free sugars. The effect of this dietary change, over a period of eight weeks, will be assessed using advanced MRI testing developed at UC San Diego School of Medicine to measure liver fat.
"Amidst the uncertainty surrounding this disease, only one fact is certain: we lack the evidence necessary to establish the role of diet, generally or specifically, in NAFLD," said Dr. Peter Attia, president and co-founder of NuSI. "By identifying the specific dietary triggers of NAFLD, we gain the knowledge necessary to improve the lives of the millions of children and adults who currently have the disease, and, more importantly, to prevent others from developing it."