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Binge Eating and Chromium Study (BEACh)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00904306
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : April 3, 2012
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Kimberly Brownley, 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).

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Dietary Supplement: Sugar Pill Dietary Supplement: chromium picolinate Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chromium Picolinate in Binge Eating Disorder: A Feasibility Study
Study Start Date : July 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Sugar pill
6 months treatment with placebo
Dietary Supplement: Sugar Pill
placebo oral tablet taken once per day

Active Comparator: low dose
600ug/day chromium picolinate for 6 months
Dietary Supplement: chromium picolinate
600 ug/day chromium picolinate

Active Comparator: high dose chromium picolinate
1000 ug/day
Dietary Supplement: chromium picolinate
1000 ug/day chromium picolinate for 6 months

Primary Outcome Measures :
  1. binge eating frequency [ Time Frame: baseline, 3 and 6 months, 3-month followup ]

Secondary Outcome Measures :
  1. mood [ Time Frame: baseline, 3 adn 6 months, 3-month followup ]
  2. insulin sensitivity [ Time Frame: baseline, 3 adn 6 months, 3-month followup ]
  3. body weight [ Time Frame: baseline, 3 adn 6 months, 3-month followup ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00904306

Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Alliance for Research on Schizophrenia and Depression
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Principal Investigator: Kimberly A Brownley, PhD University of North Carolina, Chapel Hill
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kimberly Brownley, Assistant Professor, University of North Carolina, Chapel Hill Identifier: NCT00904306    
Other Study ID Numbers: 3062-04003
08-0953 (GCRC #2713)
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012
Keywords provided by Kimberly Brownley, University of North Carolina, Chapel Hill:
binge eating
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Signs and Symptoms, Digestive
Picolinic acid
Trace Elements
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action