Binge Eating and Chromium Study (BEACh)

University of North Carolina (UNC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Binge Eating Disorder

Treatments: Dietary Supplement: Sugar Pill; Dietary Supplement: chromium picolinate

Study type: Interventional

Funder types: Other

Identifiers

NCT00904306

3062-04003

08-0953 (GCRC #2713)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Currently meets DSM-IV criteria for binge eating disorder (BED);
2. Is able to provide informed consent and meet study visit requirements; and
3. Is psychiatrically stable (e.g., no current suicidal or homicidal intent or other psychiatric condition that requires acute intervention).

Exclusion criteria

1. Body mass index (BMI) < 24.9 kg/m^2 (underweight or normal weight) or ≥ 40 kg/m^2 (severely obese);
2. Postmenopausal;
3. Age < 18 or > 55 years;
4. Pregnant, planning on becoming pregnant during the study period, or lactating;
5. Current psychotropic medication use;
6. Current use of insulin or other medications to control glucose metabolism;
7. 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.];
8. Fasting glucose level > 126 mg/dL (indicative of diabetes); and
9. Creatinine level indicating renal insufficiency (> 1.0 for women; > 1.2 for men).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 3 patient groups, including a placebo group

Sugar pill

Placebo Comparator group

Description:

6 months treatment with placebo

Treatment:

Dietary Supplement: Sugar Pill

low dose

Active Comparator group

Description:

600ug/day chromium picolinate for 6 months

Treatment:

Dietary Supplement: chromium picolinate

Dietary Supplement: chromium picolinate

high dose chromium picolinate

Active Comparator group

Description:

1000 ug/day

Treatment:

Dietary Supplement: chromium picolinate

Dietary Supplement: chromium picolinate