Binge Eating and Chromium Study
- Conditions
- Binge Eating Disorder
- Interventions
- Dietary Supplement: Sugar PillDietary Supplement: chromium picolinate
- Registration Number
- NCT00904306
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
The purpose of this study is to test the feasibility and preliminary efficacy of a 6-month chromium picolinate (CrPic) treatment trial in binge eating disorder (BED).
- Detailed Description
Binge eating (i.e., the consumption of unusually large amounts of food with a sense of loss of control) is a common problem with serious public health implications in large part due to its role in obesity. Binge eating leads to weight gain and is common in overweight individuals. Current treatments for binge eating disorder (BED) are inadequate, and previous randomized treatment trials have suffered from high drop out rate due to the adverse effects of pharmacological agents. Chromium picolinate is a dietary supplement that has been shown to reduce symptoms of depression and appetite regulation problems in patients with atypical depression; chromium picolinate also affects insulin regulation and has been shown to improve glucose levels in patients with type-2 diabetes. This pilot study will evaluate the effect of chromium picolinate on binge eating, mood, body weight, and glucose regulation in overweight individuals with BED.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Currently meets DSM-IV criteria for binge eating disorder (BED);
- Is able to provide informed consent and meet study visit requirements; and
- Is psychiatrically stable (e.g., no current suicidal or homicidal intent or other psychiatric condition that requires acute intervention).
- Body mass index (BMI) < 24.9 kg/m^2 (underweight or normal weight) or ≥ 40 kg/m^2 (severely obese);
- Postmenopausal;
- Age < 18 or > 55 years;
- Pregnant, planning on becoming pregnant during the study period, or lactating;
- Current psychotropic medication use;
- Current use of insulin or other medications to control glucose metabolism;
- Current use of medications known to significantly influence appetite or weight [i.e., over-the-counter appetite suppressants that contain phentermine or sibutramine, atypical antipsychotic agents with high weight gain liability (such as olanzapine, risperidone, etc), prednisone, etc.];
- Fasting glucose level > 126 mg/dL (indicative of diabetes); and
- Creatinine level indicating renal insufficiency (> 1.0 for women; > 1.2 for men).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugar pill Sugar Pill 6 months treatment with placebo low dose chromium picolinate 600ug/day chromium picolinate for 6 months high dose chromium picolinate chromium picolinate 1000 ug/day
- Primary Outcome Measures
Name Time Method binge eating frequency baseline, 3 and 6 months, 3-month followup
- Secondary Outcome Measures
Name Time Method mood baseline, 3 adn 6 months, 3-month followup insulin sensitivity baseline, 3 adn 6 months, 3-month followup body weight baseline, 3 adn 6 months, 3-month followup