Binge eating – the core symptom of binge eating disorder (BED) – is a serious public health concern by virtue of its comorbidity with obesity and depression. The etiology of BED is uncertain, but negative affect and food cravings have been identified as important triggers of binge eating. Current pharmacological treatments for BED are inadequate, in part, because they fail to fully address these triggers and/or are fraught with side effects that hinder adherence. Treatment drop out secondary to medication side effects has been a significant problem in BED clinical trials. Thus, novel treatments that address these modifiable triggers and are acceptable to patients are needed. Prior studies have shown that chromium supplementation can improve mood, appetite, and glucose regulation in several patient populations other than BED that are prone to over-eating, depression, weight gain, and metabolic dysregulation. This application proposes a randomized, placebo-controlled, dose-ranging intervention study of chromium supplementation in overweight individuals with BED – a patient group for whom these issues are particularly salient. Specific Aim 1 will test the feasibility of conducting a chromium picolinate (CrPic) intervention study in overweight patients with BED in an academic outpatient clinical research setting. Measures of feasibility will pertain to logistics (recruitment, retention, attrition, and treatment liking/acceptability; dosing, tolerability, and side effects; protocol implementation and participant adherence; and performance and acceptability of study measures, procedures, and instruments). Data obtained from this pilot study will be used to estimate the sample size needed for demonstrating CrPic effectiveness in overweight BED patients in a larger clinical trial. Specific Aim 2 will test the preliminary efficacy of CrPic in reducing binge frequency, negative affect (depression), sweet cravings, and body weight. After a 1-month placebo run-in phase, 60 participants will be randomized 1:1:1 to receive 1000µg/day CrPic, 600µg/day CrPic, or placebo. Assessments will take place before, after 3 and 6 months of treatment, and at 3-month follow-up. Findings from this investigation have the potential to result in the creation of an effective and acceptable intervention that will reduce core BED pathology. In doing so, this study has the potential to curtail our current obesity epidemic, as well. Findings from this study also have the potential to advance our understanding of the mechanisms through which chromium influences eating behavior and body weight regulation, and may lead to novel studies of appetite regulation neurocircuitry and brain-gut pathways involved in the psychobiology of binge eating and BED.
|Effective start/end date||7/1/08 → 6/30/11|
- The Brain and Behavior Research Foundation (National Alliance for Research on Schizophrenia and Depression (NARSAD))