Binge Eating and Chromium Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chromium Picolinate in Binge Eating Disorder: A Feasibility Study

Conditions
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Binge Eating Disorder

Intervention / Treatment
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* Dietary Supplement: Sugar Pill
* Dietary Supplement: chromium picolinate
* Dietary Supplement: chromium picolinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pill<br>6 months treatment with placebo | Dietary Supplement: Sugar Pill<br>* placebo oral tablet taken once per day<br>|
| Active Comparator: low dose<br>600ug/day chromium picolinate for 6 months | Dietary Supplement: chromium picolinate<br>* 600 ug/day chromium picolinate<br>|
| Active Comparator: high dose chromium picolinate<br>1000 ug/day | Dietary Supplement: chromium picolinate<br>* 1000 ug/day chromium picolinate for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| binge eating frequency |  | baseline, 3 and 6 months, 3-month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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binge eating, chromium, mood, glucose, appetite