A University of Miami Miller School of Medicine gastroenterologist is kicking off a new clinical study that could provide important insights into managing Crohn’s disease and other inflammatory bowel disorders through a change in diet. Funded with a $1.4 million grant from The Leona M. and Harry B. Helmsley Charitable Trust, the study looks at the potential benefits of a low-fat diet, coupled with the role of psychosocial support, to maintain a long-term change in eating habits for patients with Crohn’s disease.
“Patients with Crohn’s disease always wonder what they should eat,” said Maria T. Abreu, M.D., professor of medicine and microbiology and immunology, director of the Crohn’s and Colitis Center, and the Martin Kalser Chair in Gastroenterology. “Unfortunately, there is very little clinical data to answer that question of a long-term sustainable diet.”
Dr. Abreu is the principal investigator for the Miller School of Medicine study, “A Holistic Diet Intervention for People with Crohn’s Disease,” which will explore the effectiveness of a low-fat, high-fiber diet to manage symptoms, reduce inflammation, and improve overall quality of life for Crohn’s disease (CD) patients.
“The Helmsley Charitable Trust is committed to improving the lives of those with Crohn’s disease, including through lifestyle-related approaches to managing the condition,” said Shefali Soni, Ph.D., a program officer in the Crohn’s Disease Program at Helmsley. “Diet is a key environmental factor shaping gut microbiota, making dietary intervention studies an integral part of Helmsley’s efforts to find better treatments for the Crohn’s community, especially in light of growing patient interest in this approach. There is preliminary research indicating the efficacy of dietary therapy, and Helmsley’s support to the University of Miami Health System will further advance the science of how diet can help treat Crohn’s disease.”
Enrollment has begun for the study, which aims to enroll 160 patients with CD over the next three years. Participants must be between the ages of 18 and 70, and live with a spouse, parent, partner or other adult. All participants will provide clinical samples and their diet will be monitored through patient journals or Skype and clinic visits during the study.
Patients will be randomly assigned to one of three tracks in the clinical study. The control group will be given a low-fat diet guide at the time of enrollment, but no further support.
“We hope that even a one-time session with nutritional advice from a registered dietician will be helpful to patients, who frequently receive no guidance as to their diet,” said Dr. Abreu.
The second group will receive a guide and eight weeks of low-fat food (breakfast, lunch, dinner and two snacks) delivered to their homes. The third group will receive weekly counseling and both the participant and the other adult in the household will receive the low-fat food.
“Our study has two main purposes,” said Dr. Abreu. “First, we want to look at whether a diet low in fat and high in vegetable fiber will reduce the painful inflammatory symptoms of Crohn’s disease. In a prior study of patients with ulcerative colitis, another form of IBD, we found this diet was more beneficial than a traditional, baseline diet.”
The second purpose of the study is to determine if a psychosocial support component can increase participants’ adherence to the new diet. “Crohn’s is a chronic, lifelong disease, and any diet solution needs to be sustainable,” said Dr. Abreu, who is collaborating with Youngmee Kim, Ph.D., professor of psychology from the University of Miami College of Arts and Sciences, on this study. “People need to want to make the change for themselves, and not just because a doctor says it’s better for them,” said Dr. Abreu. “When a spouse, partner or parent is part of the change, the improvement in the diet is more likely to sustain over the long term. If so, that would be a giant step forward for our field.”