Binge Eating and Chromium Study

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).

Full Title of Study: “Chromium Picolinate in Binge Eating Disorder: A Feasibility Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2011

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.

Interventions

  • Dietary Supplement: Sugar Pill
    • placebo oral tablet taken once per day
  • Dietary Supplement: chromium picolinate
    • 1000 ug/day chromium picolinate for 6 months
  • Dietary Supplement: chromium picolinate
    • 600 ug/day chromium picolinate

Arms, Groups and Cohorts

  • Placebo Comparator: Sugar pill
    • 6 months treatment with placebo
  • Active Comparator: low dose
    • 600ug/day chromium picolinate for 6 months
  • Active Comparator: high dose chromium picolinate
    • 1000 ug/day

Clinical Trial Outcome Measures

Primary Measures

  • binge eating frequency
    • Time Frame: baseline, 3 and 6 months, 3-month followup

Secondary Measures

  • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • National Alliance for Research on Schizophrenia and Depression
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kimberly Brownley, Assistant Professor – University of North Carolina, Chapel Hill
  • Overall Official(s)
    • Kimberly A Brownley, PhD, Principal Investigator, University of North Carolina, Chapel Hill

References

Brownley KA, Berkman ND, Sedway JA, Lohr KN, Bulik CM. Binge eating disorder treatment: a systematic review of randomized controlled trials. Int J Eat Disord. 2007 May;40(4):337-48. doi: 10.1002/eat.20370.

Bulik CM, Brownley KA, Shapiro JR. Diagnosis and management of binge eating disorder. World Psychiatry. 2007 Oct;6(3):142-8.

Berkman ND, Bulik CM, Brownley KA, Lohr KN, Sedway JA, Rooks A, Gartlehner G. Management of eating disorders. Evid Rep Technol Assess (Full Rep). 2006 Apr;(135):1-166.

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