Binge Eating and Chromium Study

University of North Carolina, Chapel Hill26 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Binge Eating Disorder

Interventions

Sugar PillDIETARY_SUPPLEMENT

placebo oral tablet taken once per day

chromium picolinateDIETARY_SUPPLEMENT

1000 ug/day chromium picolinate for 6 months

chromium picolinateDIETARY_SUPPLEMENT

600 ug/day chromium picolinate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

binge eating frequency

Time frame: baseline, 3 and 6 months, 3-month followup

Secondary Outcomes

mood

Time frame: baseline, 3 adn 6 months, 3-month followup

insulin sensitivity

Time frame: baseline, 3 adn 6 months, 3-month followup

body weight

Time frame: baseline, 3 adn 6 months, 3-month followup

Data from ClinicalTrials.gov

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