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Completed

NCT Number: NCT00904306

Binge Eating and Chromium Study

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sugar Pill

Dietary Supplement

placebo oral tablet taken once per day

chromium picolinate

Dietary Supplement

1000 ug/day chromium picolinate for 6 months

Primary outcomes

  1. binge eating frequency

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study title

Chromium Picolinate in Binge Eating Disorder: A Feasibility Study

Acronym: BEACh

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 19, 2009
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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